Regulatory Affairs Newsletter

Regulatory

DEFRA Updates: WC 23rd February

Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU. Time updated: 12:02pm, 16 February 2026 Packaging data: what to…

DESNZ Updates: WC 23rd Feb

UK ETS: Waste quarterly data report template Page summary: Template for use by waste operators to submit waste quarterly data reports to their regulator during the voluntary monitoring, reporting and verification period. Change made: First published. Time updated: 11:11am, 19 February 2026 UK Emissions Trading Scheme (UK ETS): technical guidance and tools Page summary: Technical guidance, emission factors, and reporting…

February 17, 2026 in Environmental Newsletter, Environmental Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Plastic Packaging Tax costs per tonne increase

We would like to make members aware that HMRC are increasing the cost associated with the Plastic Packaging Tax to £228.82 per tonne, from 1st April 2026. This represents just over a £5 increase per tonne compared to 2025. You can find all of the guidance here.

February 4, 2026 in Environmental Newsletter, Environmental Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Government publishes PFAS Plan

Yesterday, the UK Government published its plan on PFAS substances, with the goal of restricting their use, monitoring their presence in the environment, and, where possible, removing them. The plan acknowledges the challenges of restricting PFAS substances, particularly in sectors such as ours where PFAS is internationally used because of its specific technical and performance properties, and the international collaboration…

February 3, 2026 in Membership News, Membership News Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

RADIANT CERSI Innovators Survey

The RADIANT CERSI has launched an innovators survey aimed at better understanding the regulatory challenges and support needs of digital health and AI innovators. The CERSI network is supported by MHRA and UKRI. RADIANT aims to bridge the gap between regulatory science and real-world innovation, creating a sustainable and inclusive ecosystem for SMEs and innovators in Digital Health and AI. RADIANT…

February 3, 2026 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

NIHR: Introduction to the EU Diagnostic Medical Devices Regulation (EU) 2017/746 – Online interactive workshop

🕰️ Tuesday, 24 February 2026, 10am to 12pm Are you developing a in vitro diagnostic device for the health sector? Are you unsure if you need to adhere to the In Vitro Diagnostic Medical Device Regulations? Or what the risk classification of your device is according to the In Vitro Diagnostic Medical Device Regulations? Or which requirements your device need…

February 3, 2026 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA cited in Parliament as MHRA annual fees are announced

Health Minister Baroness Merron last week announced in Parliament that MHRA fees will be set at £300 per year, based on Level 2 GMDN terms. This will take effect from 1 April 2026 to fund the MHRA’s post-market surveillance (PMS) activities. Overall, this move has been welcomed by BIVDA members. We were glad that the MHRA reconsidered the initial fees…

January 20, 2026 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA webinar: Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices

The MHRA are hosting a webinar on Clinical Trials (CTs) with in vitro Diagnostic (IVD) devices on Tuesday 3rd February from 2pm - 3pm. During this webinar the MHRA will present guidance and advice to sponsors who are submitting clinical trials with in vitro Diagnostic (IVD) devices. The webinar will be presented in sections including: Clinical Trials with IVDs The…

January 19, 2026 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Less than three weeks to go until BIVDA’s Regulatory Affairs Seminar

There are less than 3 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham and just a few tickets are now remaining. We are pleased to announce that Kim Young, Regional Engagement Director, RAPs will present a session on The Future of Regulatory Affairs. This year's theme is 'Think Locally, Act Globally', dedicating a day…

January 6, 2026 in Consultations, Consultations Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA: National AI Commission Call for Evidence

The MHRA have released a Call for Evidence regarding the regulation of AI in healthcare. This evidence will then inform the recommendations of the National Commission into the Regulation of AI in Healthcare. The Commission is a body which brings together experts from technology, healthcare, law, patient groups, the public, government, and the NHS. The MHRA is particularly keen to…

December 9, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Only 6 weeks to go until BIVDA’s Regulatory Affairs Seminar

There are only 6 weeks until BIVDA's Regulatory Affairs Seminar 2026 returns on 10–11 February 2026 in Birmingham — and it promises to be the must-attend event for diagnostics regulatory professionals across the UK, Europe, and beyond. This year's theme is 'Think Locally, Act Globally', dedicating a day each to UK and international regulation to help attendees maximise opportunities and…

BIVDA/NN Translations Webinar: How to Work Effectively with Language Service Providers and Translators

Taking place on 16 December, 1:00 PM – 2:00 PM GMT, NN Translations Founder Nataliya Nedkova will host a webinar about one of the most challenging, often misunderstood areas of medical device and IVD regulatory compliance: translation workflows. What will the webinar explore? 🔹 The hidden challenges behind medical and regulatory translations 🔹 How to work effectively with LSPs and…

November 26, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

BIVDA & MHRA UK MDR Classification Workshop – 4th December

Date and Time: Thursday 4th December, 11am to 3:30pm Make sure to register for BIVDA's workshop with the MHRA on the proposed classification rules, intended to be introduced under the Pre-Market SI. This is a crucial opportunity to work through the proposed IVD classification changes to the UK MDR with the MHRA and fellow BIVDA members. Members can register here.

November 6, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 3rd Nov)

Expanding the role of the private sector in nature recovery Page summary: We’re seeking evidence and insights on how to support and incentivise private sector investment in nature recovery. Change made: We are analysing your responses and we will publish a summary of responses as soon as possible. Time updated: 3:19pm, 27 October 2025 Exemptions reform to the Environmental Permitting…

October 28, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Nexperia Semiconductor Supply Exposure — feedback for DHSC

DHSC have highlighted an emerging risk to the UK medical technology supply chain following recent developments involving Nexperia, a major global supplier of legacy semiconductors. The Dutch government’s recent intervention and the subsequent Chinese export ban on Nexperia products have disrupted a significant portion of the company’s supply chain, with potential implications for the availability of critical chips used in…

October 28, 2025 in Consultations, Consultations Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

AI Growth Lab: Call for Evidence

The MHRA are seeking evidence on a pioneering cross-economy sandbox, that would oversee the deployment of AI-enabled products and services that current regulation hinders. The Lab would deliver more dynamic UK regulation. Regulatory decisions on novel technologies can often take years, but we know that regulatory sandboxes can accelerate time to market by 40%. The AI Growth Lab would support…

October 22, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates: WC 20th October

Waste Electrical and Electronic Equipment (WEEE) compliance fee for 2025 Page summary: Seeking views on whether we should set a compliance fee for 2025. We also want views on the proposal for managing this year’s fee. Change made: First published. Time updated: 9:30am, 13 October 2025 Climate adaptation reporting – fourth round guidance Page summary: Guidance for organisations on climate…

October 22, 2025 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Eudamed Workshop – 3rd December 2025, Brussels

Introduction to the EUDAMED Workshop The European Commission is organising two free hybrid workshops to support the onboarding of all concerned actors to EUDAMED, in preparation for the mandatory use of Actors, UDI/Devices, Notified bodies and Certificates and Market surveillance modules. The workshop provides an overview of the obligations under the Medical Devices Regulations (Regulation (EU) 2017/745 — MDR, and Regulation (EU) 2017/746 — IVDR). These workshops are a…

October 21, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates: WC 13th October

Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Updated the list of approved animal by-product plants in Great Britain. Time updated: 10:37am, 7 October 2025 Groupage export facilitation scheme: application Page summary: Apply to become a member of the groupage export…

October 15, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA issues updated guidance to reflect the implementation of the revised fee structure

The MHRA have issued the revised DORS Fees Guidance to reflect the implementation of the revised fee structure being implemented from 1st April 2026. We have extracted the key sections from the updated MHRA product registration webpage for members below. Fees from 1 April 2026 A new fee is planned to come into effect on 1 April 2026 and will…

October 7, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA guidance released: Clinical trials that include an in vitro diagnostic device

The MHRA has published guidance on clinical trials which include an in vitro diagnostic device. The guidance is split into three parts: definitions, using IVDs in a clinical trial, and applying for approval of a clinical trial that includes an IVD device. You can read the guidance here.

September 22, 2025 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

CELEX:32024L2749R(02): Corrigendum to Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/

I’ve highlighted items below that may impact IVDs (and Vet and RuO products) (Bold) or those impacting Vet use and RuO products but not IVDs (Italics). Corrigendum to Directive (EU) 2024/2749 of the European Parliament and of the Council of 9 October 2024 amending Directives 2000/14/EC, 2006/42/EC, 2010/35/EU, 2014/29/EU, 2014/30/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU a View article... This relates to…

September 22, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

EUDAMED onboarding – Commission’s EUDAMED Workshops: 8 Oct, Rome, Italy; 3 Dec, Brussels, Belgium

Registration is open for the new workshops on EUDAMED, organised by DG SANTE, European Commission: 8 October 2025, Rome, Italy 🇮🇹 3 December 2025, Brussels, Belgium 🇧🇪 For in person or online participation, you can register here. The workshop programme and venues are displayed at the workshops page : Audience: economic operators, notified bodies, national authorities, and other stakeholders Content:…

September 3, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes updated Government Response to the Consultation on Statutory Fees for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices yesterday. This follows a consultation in 2024 which proposed fee increases which would have made many in vitro diagnostic products unviable for the UK market. BIVDA were supported by members to respond to the consultation…

September 2, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA updated clinical trials guidance for companion diagnostics

Following BIVDA's feedback to the MHRA, on August 22nd the Government's Clinical Trials Guidance page was updated. The update includes specifics of trial submission when companion diagnostics are involved in GB. Separate IVDR related guidance applies to trials conducted in Northern Ireland. You can find the latest guidance here.

August 13, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

TOPRA Symposium 2025: 30 September – 1 October, and Masterclass

TOPRA are holding their 2025 Symposium in Berlin from 30th September - 1st October. The event promises to cover some of the most important topics affecting IVDs and medical devices, particularly those affecting the EU. You can find the agenda and booking information here. Please find below information related to TOPRA's IVD masterclass later on this year. Regulation of In-Vitro…

July 29, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

CTDA (Coronavirus Test Device Approvals) Update

The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this…

July 8, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Airlock round 2 open until 14 July

A reminder for members that applications for the second round of the MHRA AI Airlock programme close on 14 July 2025. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory…

July 1, 2025 in Highlights, Highlights Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes 2025 Business Plan

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the…

June 24, 2025 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MDR/IVDR Targeted Evaluation – Final summary report published

The European Commission has published the Final Summary Report of its Targeted Evaluation of the EU Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR). Early analysis by MedTech Europe has shown the following: Reforms should prioritise simplification, a risk-based and proportionate approach, and clearer guidance to enhance implementation. There is support for harmonised EU regulations; however, compliance costs remain…

June 23, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Airlock round 2 open until 14 July

Applications for the second round of the MHRA AI Airlock programme have opened following a successful pilot phase. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory ‘sandbox’ environment. Similar…

June 17, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

New Chair of UKCA Subgroup announced

BIVDA is pleased to inform members that James Barker (Cytocell) has accepted the post of co-chair of the UKCA Subgroup. James will work alongside the existing chair, Emma Barringer. James is a regulatory professional with almost 20 years of experience in the IVD sector, currently serving as Regulatory Affairs Manager at Oxford Gene Technology (OGT) in Cambridge, UK. Over the…

June 17, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA announce new Post-Market Surveillance (PMS) regulations have taken effect

From the 16th June 2025, new legal requirements for monitoring the safety of medical devices take effect, as part of the MHRA's broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. The reform applies to all UKCA- and CE-marked devices placed on…

June 13, 2025 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Policy papers and consultations with organisations of Animal and Plant Health Agency, Department for Environment, Food & Rural Affairs, Medicines and Healthcare products Regulatory Agency, and Office for Product Safety a

Call for comments on indicative lists for long-chain PFCAs, PFOA and PFHxS, their salts and related compounds Page summary: Requesting comments on a draft indicative list for long-chain perfluorocarboxylic acids, their salts and related compounds. Change made: First published. Time updated: 12:47pm, 2 June 2025 Interim position statement on the approach to PMT concept to support UK REACH risk management…

June 2, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

MHRA AI Airlock Webinar – 19th June

The MHRA will hold a webinar on 19th June at 10:00 - 11:30 to provide an update on the AI Airlock pilot programme that ran from April 2024 through to March 2025, including a summary of the pilot projects, early insights into recommendations and lessons learnt. You will also hear about the second phase of the programme including the key…

May 28, 2025 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Policy papers and consultations with organisations of Animal and Plant Health Agency, Department for Environment, Food & Rural Affairs, Medicines and Healthcare products Regulatory Agency, and Office for Product Safety

Government response to OEP review: implementation of the duty to have due regard to the Environmental Principles Policy Statement Page summary: The government’s response to the Office for Environmental Protection review of the duty to have due regard to the Environmental Principles Policy Statement. Change made: First published. Time updated: 10:45am, 19 May 2025 MHRA draft guideline on the use…

May 28, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 22 05 25

Highly Pathogenic Avian Influenza import restrictions: Brazil On 15 May 2025, Brazil confirmed an outbreak of Highly Pathogenic Avian Influenza (HPAI) on a commercial breeding poultry farm in the state of Rio Grande do Sul. In response, Great Britain has temporarily suspended imports of the following avian commodities from the Brazilian state of Rio Grande do Sul for consignments produced…

May 28, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Environmental Newsletter, Upcoming Events Environmental Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Free webinar | Strategic chemical list screening: Compliance and beyond

Chemical list screening today is no longer just a compliance checkbox. It’s about navigating regulatory shifts and anticipating emerging concerns to enable safer and smarter sourcing and product decisions that are globally compliant. Join us on Tuesday 11 June for the first of a two-part webinar series on Strategic chemical list screening. In Part 1, we’ll focus on Compliance and…

CLP: Publication of GB MCL Agency Opinions and ECHA consultation

Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions The next batch of GB MCL Agency Opinions are now available for download. A GB MCL Agency Opinion formally proposes the GB mandatory classification and labelling for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with…

May 19, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Working Party Chair and Vice Chair changes

BIVDA would like to update members on a number of changes to working party chairs and vice chairs. Regulatory Affairs Working Party Alison Gilles, Leica BioSystems, steps up at the Regulatory Affairs Working Party as Vice Chair, meaning that we’re back to full complement. UKCA Subgroup Emma Barringer is moving from chairing the Environmental WP to chairing the UKCA Subgroup.…

May 19, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA PMS and Vigilance reporting – Updated UK requirements

Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of…

May 15, 2025 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Call for Participation & Papers – ACAIN 2025 – 5th International Advanced Course & Symposium on Artificial Intelligence & Neuroscience, September 21-24 2025, Riva del Sole Resort & SPA, Tuscany * Course Registration: May 23 * Paper Submission: May 23

ACAIN 2025 - a conference of potential interest to members. W: https://acain2025.icas.events E: acain@icas.cc Symposium Deadline: Paper Submission (Symposium): by May 23 (AoE) https://acain2025.icas.events/symposium-call-for-papers/ https://easychair.org/conferences/?conf=acain2025 Course Deadline: Regular Registration (Course): by May 23 (AoE) https://acain2025.icas.events/course-description/ https://acain2025.icas.events/registration/ https://2025.iaiss.cc/deadlines/ LECTURERS: Panos Pardalos, University of Florida, USA Jose Principe, University of Florida, USA Maneesh Sahani, University College London, UK Jonathon Shlens, Google DeepMind,…

April 29, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Get discounted MedBoard services with your BIVDA membership

Thanks to our partnership with MedBoard, members can receive discounts on the first year of their MedBoard subscription. MedBoard is an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. empowering professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. By using the code BIVDAMEDBOARD, the following discounts will apply:…

April 11, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Windsor Framework Guidance

Updated guidance on sending parcels between Great Britain and Northern Ireland under the Windsor Frame Work Agreement. Sending parcels between GB and NI under the Windsor Framework https://eur03.safelinks.protection.outlook.com/?url=https://www.gov.uk/guidance/sending-parcels-between-great-britain-and-northern-ireland-under-the-windsor-framework&data=05%7c02%7cBen.Gordon%40dhsc.gov.uk%7c4d3150f65caf4ca81e9108dd6b8ae892%7c61278c3091a84c318c1fef4de8973a1c%7c1%7c0%7c638784966531722305%7cUnknown%7cTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7c0%7c%7c%7c&sdata=V0ZP/UtuKvvqJO8BDk3zWQskbznDFxzYfFNiWVysjx8%3D&reserved=0 Sending Parcels from a business in GB to a private individual or business in NI https://eur03.safelinks.protection.outlook.com/?url=https://www.gov.uk/guidance/how-to-send-parcels-from-a-business-in-great-britain-to-a-private-individual-or-a-business-in-northern-ireland&data=05%7c02%7cBen.Gordon%40dhsc.gov.uk%7c4d3150f65caf4ca81e9108dd6b8ae892%7c61278c3091a84c318c1fef4de8973a1c%7c1%7c0%7c638784966531779591%7cUnknown%7cTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7c0%7c%7c%7c&sdata=ahKhEX6xtelk4sTOZEe0YINehtymC5SvWHAAYiSCGT0%3D&reserved=0 Submitting the internal market movement information https://eur03.safelinks.protection.outlook.com/?url=https://www.gov.uk/guidance/submitting-the-internal-market-movement-information&data=05%7c02%7cBen.Gordon%40dhsc.gov.uk%7c4d3150f65caf4ca81e9108dd6b8ae892%7c61278c3091a84c318c1fef4de8973a1c%7c1%7c0%7c638784966531801088%7cUnknown%7cTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7c0%7c%7c%7c&sdata=SLA8tr/q7yRHqETDGxddMYnKb3YRMA1GSSy81rzNLdQ%3D&reserved=0 Overarching Windsor Framework Page https://eur03.safelinks.protection.outlook.com/?url=https://www.gov.uk/guidance/internal-market-movements-from-great-britain-to-northern-ireland&data=05%7c02%7cBen.Gordon%40dhsc.gov.uk%7c4d3150f65caf4ca81e9108dd6b8ae892%7c61278c3091a84c318c1fef4de8973a1c%7c1%7c0%7c638784966531821480%7cUnknown%7cTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7c0%7c%7c%7c&sdata=GO9Tb/u2JDngZ54O/8Suj1VoW8HPdZzHw7xGRGdxLCA%3D&reserved=0

April 11, 2025 in Environmental Newsletter, Environmental Newsletter Archive, European Chemicals Agency Updates Environmental Newsletter, European Chemicals Agency Updates Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

CLP: Publication of GB MCL Agency Opinions

February 25, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA’s Rob Reid pens first MedRegs blog in new role

Following the departure of Laura Squire, Dr Robert Reid, MHRA Deputy Director, will now author the regular MedRegs blog. For the uninitiated, the blog aims to keep readers up-to-date with the progress of the MedTech regulatory reform programme. Dr Reid's inaugural post focuses on staff changes at the MHRA, updated guidance, the progress of the AI airlock, and the PMS…

February 21, 2025 in Environmental Newsletter, Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

CLP: publication of GB MCL Agency Opinions and Public consultations

Please find here the updated BIVDA version of the GB MCL list highlighting divergence from EU opinions. Please note that this list updates the GB MCL Agency opinions, but these latest updates have not been adopted into GB law as yet.

The Greenhouse Gas Emissions Trading Scheme (Amendment) (No. 2) Order 2025

The Greenhouse Gas Emissions Trading Scheme (Amendment) (No. 2) Order 2025 The United Kingdom Emissions Trading Scheme (the “UK ETS”) was established by the Greenhouse Gas Emissions Trading Scheme Order 2020 (the “UK ETS Order”). The UK ETS runs for 10 “scheme years”, currently split into two 5-year “allocation periods”. Operators of certain industrial installations are required to monitor, submit…

February 19, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…

February 12, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA announce partnership with MedBoard

BIVDA is excited to announce a new partnership with MedBoard, an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. MedBoard empowers professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. As part of this collaboration, BIVDA members can enjoy exclusive discounts on their first-year MedBoard subscription – a…

February 4, 2025 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

AI/ML Software as an IVD Chair and Vice-Chair Nominations

Following the call for nominations for the role of chair and vice chair for the AI/ML Software as an IVD subgroup, we have received two nominations. Please find below statements from the two candidates. If we receive no objections by Close of Business Friday 14th Feb 2025, the nominees will be appointed. Tsz Wai Woo – IVDeology - Nominee -…

February 3, 2025 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming active substance renewals, expiries and approvals

Apply for active substance renewal by the deadlines to keep products on the NI market 29 April 2025 Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7 (PHMB (1415;4.7)) (CAS 1802181-67-4 / 32289-58-0 EC n/a) in product types 2 and 4 30 July 2025 Hydrogen peroxide (CAS 7722-84-1 EC 231-765-0)…

February 3, 2025 in Environmental Newsletter, Environmental Newsletter Archive, European Chemicals Agency Updates Environmental Newsletter, European Chemicals Agency Updates Environmental Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Biocides: EU active substance non-approval and approval decisions

New EU active substance non-approval decisions Biocidal products must be phased off the NI market p-toluene (CAS 20018-09-1 EC 243-468-3) in product types 6, 7, 9 and 10 Biocidal products containing these active substances in the relevant product types can no longer be: supplied in NI after 23 December 2025; or used in NI after 23 June 2026 You must…

January 30, 2025 in Environmental Newsletter, Environmental Newsletter Archive, European Commission Updates Environmental Newsletter, European Commission Updates Environmental Newsletter Archive, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance)

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance) The EU has published the updated regulation regarding packaging and packaging waste. Regulation (EU) 2025/40 of the European Parliament and of the Council of…

January 29, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Seven CERSIs funded to improve UK regulatory science

Innovate UK, in partnership with the MHRA, Office for Life Sciences and the Medical Research Council (MRC), has announced £6.2 million in funding for seven CERSIs (Centres of Excellence for Regulatory Science and Innovation). Each of the seven CERSIs will receive up to £1 million each. The funding will help to develop advancements in healthcare, including the use of AI,…

January 15, 2025 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Release Post-Market Surveillance Guidance

The MHRA have released their guidance on new GB PMS requirements, introduced with the new PMS Statutory Instrument. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Device Regulations 2002. The MHRA recommends members to start using the guidance immediately, to ensure you are prepared for when the new PMS requirements become mandatory from…

January 14, 2025 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Biomedical Alliance in Europe publish policy recommendations on MDR and IVDR

The BioMed Alliance has released two policy documents which include recommendations from healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, they believe there are certain shortcomings that must be…

December 18, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Medical Devices Regulatory Reform: Roadmap to implementation

The MHRA has published a revised roadmap, providing a further update on the intended timelines to implement the future medical device regulations. This new revision provides updates in four key areas, along with associated milestones and expected timelines for each. Please see here for more information.

December 9, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA trials five innovative AI technologies as part of AI Airlock pilot

Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock, a pilot scheme to better understand how to regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible. These…

December 9, 2024 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

2025 BIVDA Regulatory Affairs Seminar agenda released

The agenda for BIVDA’s 2025 Regulatory Affairs Seminar in Birmingham on February 11 - 12 2025 has now been released. Expert figures in diagnostics regulation including David Lawson, Director of Medical Technology, Department of Health and Social Care; Robyn Meurant, Principal Consultant, ACT-IVD; and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs, Thermo Fisher, will lead sessions designed to…

December 5, 2024 in Environmental Newsletter, Environmental Newsletter Archive, European Chemicals Agency Updates Environmental Newsletter, European Chemicals Agency Updates Environmental Newsletter Archive, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Commission receives scientific advice on One Health approach in the EU

Commission receives scientific advice on One Health approach in the EU The European Commission has today formally received the evidence review report and opinion of the Scientific Advice Mechanism (SAM) on One Health governance in the EU. The opinion sets out a series of policy recommendations on how the One Health approach could be managed and governed in the EU.…

November 20, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA announce new Chair

Anthony Harnden has been appointed as the new chair of the Medicine and Healthcare products Regulatory Agency (MHRA). Anthony is a Professor of Primary Care at the University of Oxford, and until the end of December 2024, a registrant Council member of the General Medical Council and Chair of the Renumeration Committee. He worked for the NHS for 40 years…

November 19, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA consultation on Medical Devices Regulations for routes to market and IVDs

The MHRA last week opened their consultation on Medical Devices Regulations for routes to market and in vitro diagnostic devices. This relates to the proposed pre-market Statutory Instrument which is planned to be laid before parliament next year. The MHRA are seeking views as a number of changes have occurred since they previously consulted last year. Areas are: - International…

November 13, 2024 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Successful Regulatory Strategy: Best Practices for the Diagnostic Sector

Our 2025 Regulatory Affairs Seminar is bringing together expert speakers to show how to develop a successful regulatory strategy; from bringing products to the market to navigating post-market surveillance. With confirmed speakers from BSI, MedTech Europe, TUV Sud, and the MHRA, the two-day event on 11th and 12th February 2025 is one not to be missed by regulatory specialists. BIVDA's…

November 5, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Online course: TOPRA IVD Regulatory Affairs for Global Markets

TOPRA’s Regulatory Affairs for Global Markets course takes place on 19-20 November and will be co-chaired by BIVDA’s Chair of the Regulatory Affairs Working Party, Stuart Angell, and BIVDA alumni, Ashleigh Batchen, now of TUV SUD. This two-day CRED course will cover the latest updates in globalmarkets including the US, Canada, China and Brazil and will also address key areas…

October 22, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

BSI Meet the Experts: In Vitro Diagnostics Regulation event – BIVDA Member 25% Discount

The BSI Meet the Experts: In Vitro Diagnostics Regulation event is taking place in Amsterdam on 27 November 2024. BIVDA members can get a 25% discount for the event. Make sure to use the code MTENLBIVDA at checkout. BIVDA members can register for the event here. This IVDR focussed event has been designed for regulatory professionals, specialists and consultants from…

October 22, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA Statutory fees for SMEs: Webinar Recording

The MHRA have released the recording of their webinar on statutory fees for SMEs. If you wish to watch the 15 min recording, click here.

September 24, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Join the MHRA AI Airlock Pilot

Applications have now opened to join the MHRA's AI Airlock pilot. You must submit your application before 7 October 2024. The application process is designed to gather information about AI Medical Devices (AIaMD) and prototypes and evaluate their suitability for the AI Airlock pilot. They MHRA are seeking to recruit 4-6 candidates to form the pilot cohort that cover a…

September 24, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

BIVDA’s Professor Mike Messenger to speak at global IVD webinar

BIVDA's Head of Regulatory Strategy Professor Mike Messenger will participate in an insightful panel event on IVD regulations alongside fellow global experts on 10 October. The event will cover regulatory landscapes across different territories, providing essential insights into regional requirements and compliance strategies. The panel of industry leaders, regulatory experts, and compliance specialists will guide you through the nuances, challenges,…

Draft regulations for the post market surveillance of medical devices update

Last week, Health Minister Baroness Gillian Merron has announced that draft regulations for the post market surveillance of medical devices will be laid before Parliament by the end of the year. These draft regulations will place more stringent demands on manufacturers when reporting incidents to the MHRA. Higher risk devices will also be subjected to additional surveillance. More updates will…

September 17, 2024 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

2025 Regulatory Affairs Seminar

The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate. Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…

September 10, 2024 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MHRA Fees Consultation Response

The MHRA recently announced a consultation on their statutory fees, running until 24th October. BIVDA have significant concerns about the suggestion of charging per GMDN code. As drafted, this could see fees increasing dramatically - from low hundreds of pounds to tens of thousands annually. The current regulatory transition may also see duplicate charging, where the same device is currently…

September 3, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA launch statutory fees consultation

The MHRA last week launched a consultation on statutory fees proposals for April 2025 until March 2027. Unsurprisingly, the trajectory is upwards - in some cases (such as clinical trials) significantly. BIVDA’s Head of Policy and Programmes, Paul Fisher noted, "These proposed increases will disproportionately impact SMEs - the sector that the government and NHS recognise as a key part…

August 27, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Common specifications for IVDs for parasites, viruses proposed by European Commission

The European Commission has suggested revising the common specifications for certain class D in vitro diagnostic devices to address tests for specific parasites and viruses of public health importance. Stakeholders have a four-week period to provide feedback on these proposed changes. On 19 August, the Commission released the proposed amendments, which, if approved, would update the In Vitro Diagnostic Medical…

August 23, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA AI Airlock Webinar from July 2024 available

The MHRA have uploaded their webinar covering the AI Airlock from July, which may be of interest to members. The webinar provides a helpful overview of the utilisation of the Airlock for the development of AI IVDs. It can be accessed here.

July 16, 2024 in Chemical Watch Updates Environmental Newsletter, Chemical Watch Updates Environmental Newsletter Archive, Environmental Newsletter, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Upcoming Events Environmental Newsletter, Upcoming Events Environmental Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Webinar: Reconciling consumer and professional labeling requirements in the US

24 July 2024 This session, led by experts from H2 compliance, aims to clarify labeling for consumers and professionals in the US by: reviewing applicable regulations and OSHA interpretation letters on the consumer-professional labeling scenario; reviewing the differences and similarities between each set of labeling requirements; and presenting an example method for unifying the labeling elements onto one product label.…

July 16, 2024 in Environmental Newsletter Archive, Export Working Party, Export Working Party Archive, Other Updates Environmental Newsletter, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter

States to Drive Mandatory Climate Reporting Forward in U.S. in Absence of SEC Rules: Sustainable Fitch

New laws and regulations at the state and federal levels in the U.S. are anticipated to create mandatory requirements for thousands of companies to provide climate-related reporting, in areas including value chain emissions and climate-related risks, even in the potential absence of climate reporting rules from the Securities and Exchange Commission (SEC), according to a new report by Fitch Group’s…

July 3, 2024 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of EU legislation amended (June 2024)

A couple EU legislative changes have taken place recently. Notably, these include changes to: Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/ECText with EEA relevance Regulation (EU) 2024/1735 of…

May 29, 2024 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of UK legislation amended (Apr-May 2024)

Multiple UK legislative changes have taken place recently. Notably, these include changes to: UK The Product Safety and Metrology etc. (Amendment) Regulations 2024, impacting non-sectorial legislation potentially applicable to IVDs. The Supply of Machinery (Safety) Regulations 2008 (legislation.gov.uk) The Ecodesign for Energy-Related Products Regulations 2010 (legislation.gov.uk) The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment…

May 22, 2024 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter

MHRA launches public consultation on common specifications for high-risk IVDs

The MHRA have launched a 4-week public consultation on common specification requirements for high risk IVDs. They are seeking views on the inclusion of these requirements for certain high-risk IVDs and on the removal of the Coronavirus Test Device Approval (CTDA) process from UK MDR 2002. The common specification policy intends to improve the safety profile of high-risk IVDs and…

April 17, 2024 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of EU and UK legislation amended (Mar-Apr 2024)

Multiple EU and UK legislative changes have taken place recently. Notably, these include changes to: EU legislations: Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of…

March 27, 2024 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of UK legislations amended

Multiple UK legislative changes have taken place recently. Notably, these include changes to: The Animals (Scientific Procedures) Act 1986 (Fees) Order 2024 The Waste Enforcement (Fixed Penalty Receipts) (Amendment) (England and Wales) Regulations 2024 The Procurement Act 2023 (Commencement No. 2) Regulations 2024 The Biocidal Products (Health and Safety) (Amendment and Transitional Provision etc.) Regulations 2024 The Environmental Protection (Disposal…

February 14, 2024 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of EU and UK legislation amended

Multiple EU and UK legislative changes have taken place recently. Notably, these include changes to: EU legislations: Commission Implementing Decision (EU) 2023/2723 of 6 December 2023 on harmonised standards for electrical equipment drafted in support of Directive 2014/35/EU of the European Parliament and of the Council: Note: IVDs are outside of the scope of the low voltage directive, however members placing…

December 20, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

ISO 13485 Stakeholder Feedback Survey

In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…

November 17, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Preparations for Revisions to ISO 13485 – User survey

November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…

November 10, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations

October 27, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

TEAM-NB Notified Bodies call to action to manufacturers to apply

Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…

October 13, 2023 in Other Updates Environmental Newsletter, Other Updates Environmental Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Regulatory Newsletter Environmental, Regulatory Newsletter Regulatory

California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost

California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost - ESG Today ESG REPORTING/ GOVERNMENT California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost Mark Segal October 9, 2023 California Governor Gavin Newsom signed two new landmark climate-related disclosure bills on Saturday, which will require large companies to disclose their value chain emissions…

September 1, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Dynamic list of standards applicable to IVDs, in collaboration with BSI

BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs. While the list aims to provide a clear and…

July 28, 2023 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter

Draft post-market surveillance statutory instrument published on WTO website

The draft statutory instrument for post-market surveillance requirements under the new UKCA regime has been published on the World Trade Organisation website. The notification can be found here. The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 is applicable to Great Britain only. It introduces a new part, Part 4A, which defines the post-market surveillance requirements of…

July 21, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

BIVDA and MHRA bilateral meeting held on 18 July

On 18 July, BIVDA and MHRA met for our latest one-on-one meeting. The aim of these meetings is to ensure our relationship remains strong and we are able to collaborate on projects key to the IVD sector. The discussions are in addition to our usual day-to-day work with MHRA, specifically involving MHRA’s senior and executive staff. MHRA recently published their…

July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Various pieces of UK legislation amended

Multiple UK legislative changes have taken place recently. Notably, these include changes to: The Persistent Organic Pollutants (Amendment) Regulations 2023 - These regulations amend Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants (recast) (OJ No L 169, 25.6.2019, p 45) to extend the period for which the specific exemption in Annex 1 applicable…

June 30, 2023 in BIVDA Updates Environmental Newsletter, BIVDA Updates Environmental Newsletter Archive, BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive

Ashleigh to leave BIVDA, and Stuart Angell to join the team

It is bittersweet to let you all know that I will be leaving my role as Head of Regulatory Affairs at BIVDA, with my last working day being 25 August. I have loved my time working with the BIVDA secretariat and the BIVDA membership, and I’m sure I will cross paths with many of you again in the future!…

May 12, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

EU Notified bodies urging to submit Class D legacy devices’ application sooner

As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.

May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

APHA weekly update (WC 01 May)

Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Updated the approved animal by-product plants in Great Britain list. Time updated: 2:06pm, 2 May 2023 Animal by-products for purposes outside the feed…

May 5, 2023 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA survey on PMS costs – deadline 17 May

To better understand the implications of proposed Post Market Surveillance (PMS) to manufacturers of medical devices, the MHRA would like to be provided with data on firms' expected cost of compliance with PMS regulations so far. This survey covers total costs of setting up a PMS system across an organisation, and the cost of maintaining a PMS. This firm level…

UKCA statutory instrument published on implementation timelines

The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain. BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We…

May 5, 2023 in European Chemicals Agency Updates Environmental Newsletter, European Chemicals Agency Updates Environmental Newsletter Archive, Industry newsletters Environmental Newsletter, Industry Newsletters Environmental Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

RoHS use information requested – deadline 26 May

Recently, BIVDA joined the Joint Trade Association, a collective of Trade Associations in the electronic space. This is in response to ongoing pressure with UK RoHS and the new fee associated with submitting applications of exemption under UK RoHS. We hope that by working with JTA, we will be able to support the BIVDA membership in submitting, or collating, UK…

April 21, 2023 in BIVDA Updates Environmental Newsletter, BIVDA Updates Environmental Newsletter Archive, BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Environmental Newsletter, MedTech Europe Updates Environmental Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Request for information on labelling

There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…

April 3, 2023 in Consultations, Consultations Archive, European Chemicals Agency Updates Environmental Newsletter Archive, European Commission Updates Environmental Newsletter, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

European Commission consultation on Directive to promote the repair of goods

The European Commission have launched a public consultation on their proposal for a Directive on common rules promoting the repair of goods. This consultation is open until 22 May. This initiative promotes a more sustainable use of goods throughout their useful life. It will encourage consumers to make more sustainable choices by providing incentives and tools to use goods for…

March 31, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA has confirmed EU amendment to MDR will apply in Northern Ireland

MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…

March 24, 2023 in Funding/Grant Opportunities Environmental Newsletter, Funding/Grant Opportunities Environmental Newsletter Archive, Funding/Grant Opportunities Regulatory Affairs Newsletter, Funding/Grant Opportunities Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive

Innovate UK (UKRI) launches new funding competition

These programmes will focus on the future economy as described in our plan for action. The Future Economy investor partnership programme brings together: Innovate UK’s expertise in identifying innovation and using grant funding to change the risk profile of businesses investor partners’ aligned funding and expertise in identifying opportunities and teams that can best use extra investment finance More information…

March 17, 2023 in European Commission Updates Environmental Newsletter, European Commission Updates Environmental Newsletter Archive, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Environmental Newsletter, MedTech Europe Updates Environmental Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR)

There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…

March 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

APHA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Imports of poultry, ratite and wild game bird meat into Great Britain from Argentina that were slaughtered on or after 28 February…

March 9, 2023 in BIVDA Updates Environmental Newsletter, BIVDA updates Regulatory Affairs Newsletter, European Commission Updates Environmental Newsletter, FDA updates Regulatory Affairs Newsletter, Funding/Grant Opportunities Regulatory Affairs Newsletter, MedTech Europe Updates Environmental Newsletter, Other Updates Environmental Newsletter, Other Updates Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter

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March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

EU MDR/EU IVDR amendment approved by EU Council

On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…

March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DEFRA weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. Businesses urged to get ready for reforms to cut packaging waste Page summary: Reporting requirements for the Extended Producer Responsibility scheme for packaging come into force today. Change made: First published. Request for information about risk management evaluations of substances proposed as Persistent Organic Pollutants (POPs) Page summary: Collecting…

APHA weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Updated the ‘Avian influenza (bird flu) outside the UK’ section. The surveillance period for imports of live animals and fresh poultry meat…

March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. MHRA Graduate Scheme Page summary: Information about the MHRA’s Graduate Scheme and how to apply. Change made: First published. Working for MHRA Page summary: Information on how to apply for jobs, workplace benefits and skills development at the Agency. Change made: Added link to MHRA graduate Scheme. Medical…

March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb)

Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…

DEFRA weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Calculate the carbon dioxide equivalent quantity of an F gas Page summary: Find out how to express the mass of a fluorinated greenhouse gas (F gas) in terms of carbon dioxide equivalent so that you comply with regulations on F gases. Change made: Added ‘metric’ to metric tonnes for clarification.…

APHA weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated name and contact details for ATD Export Services Limited in the…

March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

DHSC MedTech Directorate holding webinar on the Medical Technology Strategy

DHSC have provided the following update for stakeholders: The DHSC Medical Technologies Directorate is hosting a webinar on Monday 6 March 2023 at 11:00 – 12:00 to promote the newly published Medical Technology Strategy which was shared with you on 3 February 2023 (https://www.gov.uk/government/publications/medical-technology-strategy). The Government’s inaugural Medical Technology Strategy sets out how we will ensure the health and social…

March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Team-NB position paper published: guidance for submission of technical documentation

Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…

EMA pilot launched for expert panels on high risk medical devices

For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…

Regulatory

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CLSI Standard PRE06 – Evaluation of External Transport Systems

Your latest One IPO Patent Service update!

UK-China Intellectual Property Newsletter

MHRA Updates: WC 2nd March

DEFRA Updates: WC 2nd March

Animal and Plant Health Agency Updates: WC 2nd March

UK Common Frameworks

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Machinery safety legislation: call for evidence

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HRA Latest – 27 February 2026

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Register medical devices to place on the market

MedTech Europe – EUDAMED

EU funding available for health research

New resources on market actions and minor PRAC updates

Use of legislative powers related to recalls and other market actions

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MedTech Europe – Clinical evidence requirements ebook fourth edition published

WHO Position Note on Accessories

NICE – Statement of intent – NICE’s approach ongoing evaluations ahead of proposed changes to NICE’s standard cost-effectiveness thresholds

From Dialogue to Action: A Month of Global Engagement

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Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27

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Animal and Plant Health Agency: WC 23rd February

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Office for Product Safety and Standards Updates: WC 23rd February

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DBT Updates: WC 23rd February

DEFRA Updates: WC 23rd February

DESNZ Updates: WC 23rd Feb

MHRA Update: WC 23rd February

UKRI strategy builds on UK’s strength and potential in AI

Biocides: Upcoming EU active substance renewal submission deadline and approval date

Protected: MedTech Europe Sustainable Corporate Governance Working Group – Call for Evidence

CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief

Publication of UK Sanctions List Search Tool: User Guide – 12 February 2026 (Updated Links)

FDA Town Hall – Real World Evidence Guidance

Biocides: Upcoming EU active substance dossier submission deadlines and expiry date

Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report

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EC Call for Feedback on Draft DA on Waste Framework Directive

APHA Business Readiness Forum Newsletter

How do you prove that your AI systems work as intended – not just say that they do?

Call for evidence on ownership and control in financial sanctions regulations

South Korea issues updated Medical Device GMP Regulations 2026/02

Office for Product Safety and Standards: WC 16th Feb

DHSC Updates: WC 16th Feb

MHRA Updates: WC 16th Feb

Take a deep dive into EU cardiovascular health data

Consultation: TGA fees and charges proposal 2026-27

The Trade in Endangered Species of Wild Fauna and Flora (Council Regulation (EC) No 338/97) (Amendment) Regulations 2026

Medicines and Medical Devices Act 2021: 5 year report – GOV.UK

Support your business by signing up for our IP workshop in Manchester

Medical Device Regulations in Mexico 2026

DEFRA Updates: WC 16th Feb

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Plastic Packaging Tax costs per tonne increase

Biocides: GB active substance expiry dates and renewal deadline

Public advised to stop using some non-sterile alcohol-free wipes

Funding and Support news from the NIHR

Identifying sepsis cases in administrative data: a validation study

FDA Guidance Updates

BSI Standards update

The Data (Use and Access) Act 2025 (Commencement No. 6 and Transitional and Saving Provisions) Regulations 2026

EU report emphasizes need for high value cancer care for all

Medical Devices: Register now for high-level conference on 16 March 2026

Health Security Committee: Timely sharing of information and coordination of response