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Cystic Fibrosis Trust Industry Symposium

By Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
The Cystic Fibrosis Trust are hosting an industry symposium "Accelerating CF Research: Strategies for rapidly progressing your science to clinical impact" on the 05 June 2024 in Glasgow. This event aims to showcase the support available for researchers to tap into and ways to accelerate their research projects. More information on this event and registration can be found here.
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May 8, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

BSI webinar on achieving net zero goals

BSI are hosting a free webinar on how a small business can achieve net zero goals on 11 June. The webinar will include include an introduction to BSI Flex 3030 and what it aims to do, user community discussion on BSI Flex 3030, how best it can be applied, and its impact, a Q&A session and audience feedback and introduction…
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May 1, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
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April 24, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Qserve free webinar: EU-IVDR two years on!

Qserve are hosting a free webinar on "EU-IVDR two years on!" where Sue Spencer will explain what the proposed extension of the IVDR means for manufacturers and how IVD manufacturers can understand and effectively use the IVDR transition for successful CE marking. This webinar aims manufacturers to help them by sharing the current state of play, what is the extension…
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April 17, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

Call for expertise on the development of IEC 61010-2-101

BSI are looking for experts 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), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
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February 14, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

BSI webinar on the impact of the EU AI Act

BSI are hosting a webinar about updates on the EU AI Act progress, covering its history, the significant elements of the recent December deal, and its potential impact on various industries on 27 February. The webinar will include an explanation on EU AI Act and strategies to prepare for the Act's implementation. Members who are interested in attending this webinar…
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February 14, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Upcoming webinars

ISO 37001: How to prepare for the certification process ISO 37001 is an international standard on Anti-bribery management systems that allows organizations of all types to prevent, detect and address bribery. Speeki Pte Ltd are hosting a webinar about the the ISO 37001 certification process on 22 February. The webinar will include practical advice on preparing for a successful ISO…
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January 31, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

IP and Business Growth Survey 

Intellectual Property Office are inviting businesses to respond to our survey on IP and business growth. They are asking businesses to share their views on the role intellectual property plays in supporting the growth of their business. The survey is split into the following sections: Section 1 covers information about your business. You will be asked questions on your location,…
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January 24, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
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January 3, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

New available International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: ISO/IEC/TR 24027:2023 - Information technology - Artificial intelligence (AI) - Bias in AI systems and AI aided decision making and ISO/IEC TR 24029-1:2021 - Artificial Intelligence (AI) - Assessment of the robustness of neural networks - Part 1: Overview. These standards are available from 20 December.
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December 20, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

UL Standards update (WC 30 Nov)

UL have published the following documents between 30 November and 15 December: Standard UL 2900-1 Ed. 2 Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements CSDS Proposal UL 62133-2 Ed. 1 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, for Use in Portable…
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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…
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December 8, 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

New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
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November 24, 2023 in 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 RAC

This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
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November 24, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

BSI webinar on EU IVDR regulatory updates

BSI are hosting a webinar about the latest IVDR regulatory updates on 28 November. The webinar will include a short recap on where the IVDR is, along with latest MDCG guidance and developments in Brussels; description of the challenges for Class D IVD’s and the status on EU Reference Labs and envision the potential ramifications for manufacturers of these updates.…
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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

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…
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