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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…
Ben Kemp
February 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

How to prepare for the new Post-market Surveillance Requirements in Great Britain

25 March 2025 | 09:00 and 16:00 GMT Join us for our PMS in Great Britain webinar on 25 March 2025 This insightful webinar will introduce the PMS requirements under the new regulations in Great Britain for Post-market Surveillance. Our speakers will provide an overview of the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR. In addition, an update/…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Join the RAPS Workshop: Cybersecurity for Medical Devices 

Cybersecurity remains a top priority for medical device manufacturers   Cybersecurity Unauthorized Attend from anywhere: 25 – 26 March 2025, 9 am - 5 pm ET   This interactive virtual workshop will provide crucial insights into navigating global cybersecurity regulations and developing effective strategies to strengthen your submissions and compliance processes.   After completing this two-day workshop, you will be…
Ben Kemp
February 21, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveRegulatory Affairs Working Party Archive

MDCG – 2019-6 Rev 5 Q&A: Requirements relating to notified bodies

EU MDCG have published the 5th Revision of the Q&A: : Requirements relating to notified bodies – MDCG 2019-6 Rev 5 Although applicable to EU Notified bodies, it is useful to see what the EU Competent authorities are asking notified bodies to require, and allows companies to prepare supporting evidence accordingly. The latest update includes improved content on structured dialogue,…
Ben Kemp
February 21, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Joint MedTech Europe/COCIR Reflection Paper on MDSAP

MedTech Europe and COCIR have jointly published their position paper asking for the UE to join as a full member of MDSAP (Medical Device Single Audit Program). This aligns with our own position that the UK should also join, and make MDSAP optional alongside the current ISO 13485 Certification program regarding Quality Management Systems certification. You can read it here.
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 16 Feb)

MHRA Real-World Evidence Scientific Dialogue Programme Page summary: A programme to help decision-making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations. Change made: Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot Time updated: 12:01am, 10 February 2025     Digital mental health technology: qualification…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 16 Feb)

Visiting the UK as an EU, EEA or Swiss citizen Page summary: What you need to know about crossing the UK border and visiting the UK. Change made: Added details about who will need an electronic travel authorisation (ETA) from 2 April 2025, and who will not need an ETA. Time updated: 2:47pm, 10 February 2025
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates (WC 16 Feb)

Reporting to the National Supply Disruption Response (NSDR) Page summary: Information on how to request assistance from the NSDR. Change made: Updated to promote earlier contact with the NSDR in a disruption response situation. Time updated: 10:01am, 11 February 2025 Government ramps up efforts to end HIV transmissions in England Page summary: Over 20,000 self-testing and self-sampling kits will be…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 16 Feb)

AI Growth Zones: expression of interest Page summary: Regional authorities, local authorities and industry are invited to submit an expression of interest for the development of AI Growth Zones. Change made: First published. Time updated: 12:01am, 10 February 2025 Government fires starting gun on AI Growth Zones to turbocharge Plan for Change Page summary: Thousands of new jobs are set…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 16 Feb)

Notice to Importers 2953: Russia import sanctions Page summary: Import prohibitions in force under the Russia Sanctions Regulations 2019, as amended. It should be read alongside the statutory guidance. Change made: ‘Import licences’ section of ‘NTI 2953: Russia import sanctions’ updated to advise when a licence cannot be granted. Time updated: 11:39am, 10 February 2025 Import controls Page summary: How…
Ben Kemp
February 21, 2025
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