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May 26, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

CEN adopts ISO 17043 as European standard

CEN have formally adopted ISO 17043: Conformity assessment — General requirements for proficiency testing as a European standard. This may impact EQA providers providing proficiency testing services such as end user POCT schemes for staff proficiency.
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May 26, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

IBMS releases a new POCT guidance

The IBMS, in collaboration with the Royal College of Pathologists (RCPath) and the Association for Clinical Biochemistry and Laboratory Medicine (ACB), has jointly produced a new national guidance on Point of Care Testing. Members are encouraged to review this guidance.
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 May)

Please note this is an extract of the original bulletin. COVID-19 test approval: how to apply Page summary: How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Change made: Updated notice on change to the application process. Global AI challenge to investigate veterans’ cardiovascular health launched Page summary: A brand-new challenge…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Submitting Adverse Incidents to Medical Devices to the MHRA – enhancements to the MORE portal

Adverse incidents involving medical devices which occur in the UK are reported to the MHRA via the MORE portal. The MHRA is in the process of implementing several changes to make the MORE portal automatized and easier to use. These updates are expected from June onwards. The MHRA have provided the following information: In our last update, we said that…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 May)

Please note this is an extract of the original bulletin. Six new community diagnostic centres to deliver more than 500,000 lifesaving checks a year Page summary: New CDCs to open in regions across the UK, adding to the 106 centres already up and running and helping to cut NHS waiting lists Change made: First published. Health secretary attends Japan summit…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 May)

Please note this is an extract of the original bulletin. UK and Japan strengthen science and tech ties in Tokyo Page summary: UK and Japan today signed a renewed science and technology deal, building on decades of close cooperation. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 May)

Please note this is an extract of the original bulletin. UK to launch talks with Switzerland on new trade deal Page summary: UK Business and Trade Secretary, Kemi Badenoch, launches negotiations for a modern, updated free trade agreement with Switzerland. Change made: First published. UK-Switzerland enhanced free trade agreement negotiations Page summary: Documents relating to the UK and Switzerland’s negotiations for…
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May 19, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA’s new Regulatory email

BIVDA has recently established a new email address dedicated to handling all regulatory enquiries. If you have any questions, concerns, or require assistance regarding regulatory matters or any events, we kindly ask you to contact our Regulatory Affairs email (Regulatory@bivda.org.uk). This will then be managed by either Ashleigh or Tehelj. If you are awaiting a response to any questions sent…
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May 19, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

US EPA update (17 May)

Please note this is an extract of the original bulletin. Proposal removes low volume and exposure exemptions for new PFAS and other persistent chemicals, ensuring robust safety review WASHINGTON (May 16, 2023) — Today, the U.S. Environmental Protection Agency (EPA) proposed amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA)…
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May 19, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 May)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Reference guides updated and new video tutorials added. MHRA fees Page summary: Fees payable…
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May 12, 2023 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Coronavirus Test Device Approvals Transition

The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May. The MHRA have provided the following information: The UK Coronavirus Test Device Approvals regulatory regime is one of the most…
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 01 May)

Please note this is an extract of the original bulletin.   The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: The date of when the survey will…
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 May)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…
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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.
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 01 May)

Please note this is an extract of the original bulletin. EM on EU decision to amend EU Regulation 2017/745 (COM(2022)721) Page summary: The Governments summary of a proposal of the European Parliament and the Council on fees and charges payable to the European Medicines Agency. Change made: First published. Time updated: 9:48am, 3 May 2023
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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…
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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

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…
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May 5, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

BSI has adopted standard for electrical safety

BSI have adopted IEC 61010-2-101:2018 as a British standard. BS EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment considers electrical safety requirements for IVD equipment, and should be considered for manufacturers with products in this space.
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May 5, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 24 Apr)

Please note this is an extract of the original bulletin. Reporting to the National Supply Disruption Response (NSDR) Page summary: Information on how to request assistance from NSDR. Change made: Updated language used from ‘how to report’ to ‘how to request assistance’ to describe the service more accurately. Lateral flow device (LFD) performance data Page summary: LFDs have proved vital…
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May 5, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 24 Apr)

Please note this is an extract of the original bulletin. Medical devices – extended acceptance of CE marked medical devices on the Great Britain market Page summary: CE marked medical devices to be accepted in Great Britain for a longer period. Change made: First published.
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April 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 17 Apr)

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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April 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA extends MORE portal deadline to 31 August

MHRA have extended the deadline for their new MORE portal to 31 August. It was initially intended to be mandatory for vigilance reporting to MHRA from April. MHRA have provided the following information: The MHRA has been listening to feedback and engaging with device manufacturers and stakeholders since the new MORE portal was launched in November 2022. We understand that…
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April 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 10 Apr)

Please note this is an extract of the original bulletin.   Hewitt review: call for evidence Page summary: We want your views on how the oversight and governance of integrated care systems can best enable them to succeed. Change made: Added link to the Hewitt Review, which forms the outcome of this call for evidence.
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April 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 3 Apr)

Please note this is an extract of the original bulletin. UK’s next generation of medical researchers given funding boost Page summary: Investment is aimed at sparking a new wave of revolutionary medical research across the industry. Change made: First published. Occult hepatitis B infection in UK blood donors Page summary: Recommendations from the SaBTO occult hepatitis B infection (OBI) working…
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April 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 3 Apr)

Please note this is an extract of the original bulletin. MHRA fees Page summary: Fees payable to the MHRA for 2023 to 2024 Change made: Updated MHRA fees for 2023 – 2024 New statutory fees for MHRA services introduced from 1 April 2023 Page summary: Changes have been designed to ensure the agency is resourced to provide patients, the public…
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April 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Mar)

Please note this is an extract of the original bulletin.   Export medical devices Page summary: Order a certificate of free sale to export medical devices outside the UK. Change made: Updated ‘Certificates of Free Sale for Medical Devices’ PDF.   Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines…
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April 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Mar)

Please note this is an extract of the original bulletin.   Life sciences companies supercharged with £277 million in government and private investment Page summary: Four life sciences companies from across the UK will benefit from the first tranche of Life Sciences Innovative Manufacturing Fund (LSIMF) grants. Change made: First published.
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April 6, 2023 in BIVDA updates Regulatory Affairs Newsletter, Membership News, Membership News Archive, Upcoming Events Regulatory Affairs Newsletter

TOPRA training discount for BIVDA members

TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…
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April 3, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive

CPD certificate available for BIVDA Spring Regulatory Seminar

If you attended the BIVDA Spring Regulatory Seminar on 8 March, you are eligible for a CPD certificate. If  you would like to receive a certificate for your CPD log, please contact Natalie to request one (natalie@bivda.org.uk).
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April 3, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

UL free webinar on UKCA for IVD medical devices

UL have made available a 30 minute webinar on the upcoming UK Medical Device Regulation changes. This is a free webinar available from the UL website. It covers current timelines, expected requirements based on the MHRA consultation response, and transitional arrangements.
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

UKHSA weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   UK SMI S 12: sepsis and other systemic and disseminated infections Page summary: This consultation asks for feedback on UK Standards for Microbiology Investigations S 12: sepsis, and other systemic and disseminated infections. Change made: Added Review of users’ comments for S 12 Sepsis and systemic or disseminated infections.
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Consultation on proposals for legislative changes for clinical trials Page summary: We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines Change made: Government response…
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Submitting an application for review by the ACBS Page summary: How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS). Change made: Added ‘11 March 2024 – closing date for submissions is 15 January 2024’ under the heading ‘ACBS meetings and…
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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,…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   New rules for importing and exporting goods Page summary: Importing: an overview Change made: Updated to reflect the change from Department for International Trade to Department for Business and Trade
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

HMRC weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Get a goods movement reference: check service availability and issues Page summary: Check the availability and any issues affecting the get a goods movement reference service. Change made: Updated to confirm there is planned maintenance work on the Customs Declaration Service from 9:30pm on Saturday 25 March 2023 to…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 Mar)

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Consultation response on legislative proposals for clinical trials published by MHRA

MHRA has published the consultation response on their proposals for legislative changes for clinical trials. "We will introduce new legislation and guidance as part of a swathe of new measures that represent the biggest overhaul in UK clinical trials regulation in over 20 years. These bold new measures will make the UK one of the best countries in the world…
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March 24, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News

EU IVDR amendment published in the OJEU

The amendment to the EU IVDR has been published in the Official Journal of the European Union. This removes the sell-off provision for IVD products, meaning that IVDs legally placed on the market under their IVDD certification can continue to be supplied to users indefinitely. This does not mean that new product can be placed on the market after expiry…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes new software guidance for intended purpose

MHRA has published a new guidance page for developing an intended purpose in the context of Software as a Medical Device (SaMD). We encourage all members who make software products as a medical device should review this guidance for the UK market.
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument for the Windsor Framework published

The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA request to engage earlier for safety issues

MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Advisory Group Reform Proposals Page summary: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. Change made: First published. MHRA fees Page summary: Fees payable to the MHRA for 2022 to 2023 Change made: Added link to application form to ‘apply for Small and Medium Company…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Government to consider radical new approach to prevent life-threatening cardiovascular disease Page summary: Professor John Deanfield, CBE announced as the first ever Government Champion for Personalised Prevention Change made: First published. Minister meets leading researchers in women’s health and calls for more women working in STEM Page summary: Today (Monday…
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March 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance schedule

The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC webinar on the Windsor Framework

DHSC have provided the following update for stakeholders: DHSC would like to invite you to a webinar at 2pm on Thursday 16 March, on the recent announcement from the Government on the significant changes to medicines in the Windsor Framework. We will be joined by colleagues from MHRA, and will be discussing: The replacement of the EMA by the MHRA…
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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…
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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…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. England Rare Diseases Action Plan to tackle health inequalities Page summary: The 2023 England Rare Diseases Action Plan goes further than ever before to support people living with rare diseases. Change made: First published.   England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how…
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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…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Feb)

Please note this is an extract of the original bulletin. Plans to bolster patient safety and boost support for frontline staff by streamlining the system for healthcare regulators Page summary: The government will streamline the system to modernise regulatory legislation to boost patient safety and support staff Change made: First published.   Lord O’Shaughnessy to lead independent review into UK…
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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…
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March 9, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Membership News, Membership News Archive

Reminder: BSI looking for contributors for safety requirements for electrical equipment for measurement, control and laboratory use standard

A reminder that BSI have put a call out for those interested and knowledgeable in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision.…
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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…
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March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey results: Transition to the IVD Regulation

MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.    
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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

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

DHSC notice on the Windsor Framework

DHSC have provided the following update for stakeholders: You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol. This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of…
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March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

Third edition of Clinical Evidence Requirements under the IVDR eBook published

MedTech Europe have published the third version of their Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation eBook. This can be found on the MedTech Europe website.
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November 18, 2022 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Latest UKCA extensions do not apply to medical devices

This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1

Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MHRA innovation case studies – Regulatory Affairs Newsletter #1

Case studies demonstrating how MHRA has helped a number of companies navigate the regulatory processes for innovative new medicines and medical devices. Change made: Added ‘Horizon Scanning Case Study: Point of Care manufacture’ to the collection.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Innovation Accelerator – Regulatory Affairs Newsletter #1

Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Horizon Scanning Case Study: Point of Care manufacture – Regulatory Affairs Newsletter #1

Horizon scanning at the MHRA leads to a proposed new framework to enable the supply and increase in the availability of innovative new medicinal products made at the point of care to patients. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

MHRA weekly update – Regulatory Affairs Newsletter #1

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation. Change made: Updated ‘Open List’
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Health and Care Act 2022: adult social care provider information provisions – Regulatory Affairs Newsletter #1

Guidance for adult social care providers to comply with information provisions under section 99 and section 100 of the Health and Care Act 2022. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Coronavirus Act report: May 2022 – Regulatory Affairs Newsletter #1

The thirteenth two-monthly report on which powers in the Coronavirus Act 2020 are currently active. Change made: Added a correction slip to the report, detailing revisions to the document on pages 4 and 11.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Businesses approved to export to the EU – Regulatory Affairs Newsletter #1

Page summary: Use the lists to check your business in Great Britain (England, Scotland and Wales) or one of the Crown Dependencies (Jersey, Guernsey and Isle of Man) 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.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA updates – Regulatory Affairs Newsletter #1

Places are filling up for the BIVDA Joint Working Party and Regulatory Affairs Seminar! If you are looking to attend Working Party meetings or the Regulatory Affairs Seminar, we encourage you to register as soon as possible to prevent disappointment. The agenda for these are being finalised, but the seminar is aiming to cover: Summary of what is going on…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

Summary – Regulatory Affairs Newsletter #1

The BIVDA Joint Working Party and annual Regulatory Affairs Seminar is approaching on 12-13 October. Members are encouraged to book tickets as soon as possible to prevent disappointment – places are filling up fast!
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