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Office for Product Safety and Standards Update (WC 22 Sept)

Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change made: Notice of publication amended and consolidated list updated. Time updated: 12:05am, 17 September 2024 OPSS sponsored BSI PAS 7770 has been published Page summary: OPSS supports new guidance to reduce the environmental impact of electronic product design.…
Ben Kemp
September 24, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Animal testing roadmap consultation

Members are kindly invited to inform MedTech Europe if they should engage in the consultation, and if yes, share in the document at the link here, answers to the following questions: What are members’ views on the proposed actions for the future roadmap summarized above? Is there something missing? Is there support members require to gradually phase-out animal testing? E.g. research,…
Ben Kemp
September 24, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK 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…
Ben Kemp
September 24, 2024
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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,…
Ben Kemp
September 24, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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…
Ben Kemp
September 24, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Get Ahead of AI Regulations – EU AI Act Training

AI is becoming an integral part of our daily lives, and its governance affects everyone, from tech giants to individual users. Qserve will host a two-day AI Act training in Amsterdam, The Netherlands. Qserve and Industry Experts will explore this pivotal legislation and its implications for the medical device and IVD sectors during this training. Speakers include Gert Bos, Coenraad Davidsdochter,…
Ben Kemp
September 18, 2024
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Action needed now if you use EPO online filing!

Do you use EPO Online Filing (eOLF)? Things are changing on 30 September!  From 1 October 2024, you will no longer be able to renew eOLF Smart Cards that have expired. To continue filing with the IPO via eOLF, you will need to replace your smart card with a ‘soft certificate’. From 1st January 2025, valid smart cards will no…
Ben Kemp
September 18, 2024
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BSI – Rollout of EU Reference Laboratories for Class D IVDs

As part of BSI Regulatory Services, Medical Devices commitment in maintaining IVDs manufacturers up to date on the EU regulatory framework developments, we issue this communication in regard of the rollout of EU Reference Laboratories and oversight of Class D IVDs in Europe. On 5 December 2023, five EU reference laboratories (EURLs) have been designated through Commission Implementing Regulation (EU)…
Ben Kemp
September 18, 2024
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