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Regulatory Affairs Newsletter

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2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations

Members have just over 2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations. This date sees a significant update to the UK Medical Device Regulation 2002 for IVDs and medical devices. Stuart Angell, Chair of BIVDA's Regulatory Affairs Working Party, provides a rundown of what members need to know: Systematic Data Collection: Manufacturers must establish and…
Ben Kemp
June 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Become a Certified PRRC – Join Our Expert-Led Virtual Training in June

Join our Upcoming PRRC Training Under the EU MDR and IVDR, the Person Responsible for Regulatory Compliance (PRRC) plays a critical role in ensuring that medical devices meet stringent regulatory standards throughout their lifecycle. Are you prepared to take on that responsibility, or to confirm that your team is ready for it? Join our two-part virtual PRRC training on June…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

TOPRA – Essentials of In-Vitro Diagnostics Regulatory Affairs

Essentials of In-Vitro Diagnostics Regulatory Affairs 11 July 2025 | London, UK and online Master the fundamentals of IVDs with our training course. It will provide you with the confidence you need to communicate the basics of IVDs in regulatory affairs. There will be a comprehensive overview of the regulatory environment and cover the main regulatory processes and issues surrounding…
Ben Kemp
May 28, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDSAP Website

MDSAP have launched their refreshed website providing information on the Medical Device Single Audit Program. Official members include TGA Australia, ANVISA, Brazil, Health Canada, PMDA Japan, and US FDA, With the EU, HSA Singapore, MHRA UK, and WHO having joined as official observers, and ANMAT Argentina, Israel’s Ministry of Health, Kenya’s Pharmacy and Poisons Board, Republic of Korea Ministry of…
Ben Kemp
May 28, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New educational guide for the use of the European Medical Device Nomenclature (EMDN)

Manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling. To support consistent and compliant application, MedTech Europe released a practical guide to the use of the European Medical Device Nomenclature which: Assists in the…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 26 May)

Major investment partnership worth £24 billion to transform key growth sectors and deliver affordable housing across UK Page summary: A major new partnership between the Crown Estate and Lendlease has been agreed which will unlock housing and science innovation hubs across the UK worth £24 billion. Change made: First published. Time updated: 10:43am, 19 May 2025 PM secures new agreement…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 26 May)

Awarding ten-year R&D funding: guidance for departments and ALBs Page summary: What government departments and arms-length bodies (ALBs) need to consider when awarding ten-year, or other long-term research and development (R&D) funding. Change made: First published. Time updated: 12:01am, 19 May 2025 Government to set new ten-year budgets for R&D funding Page summary: New criteria to give certainty to world-class…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 26 May)

Transport goods in Europe in vans or car and trailers Page summary: What transport companies and couriers need to do to use vans and car and trailers over 2.5 tonnes to transport goods in Europe. Change made: Removed content about having a member of staff temporarily recognised as a transport manager because you can no longer apply to do this.…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 26 May)

DHSC counter-fraud policy: summary Page summary: The Department of Health and Social Care’s approach to preventing and detecting fraud, bribery and corruption. Change made: First published. Time updated: 3:13pm, 20 May 2025 UK adopts historic Pandemic Agreement Page summary: Better protections for British public and NHS thanks to deal adopted at the World Health Assembly in Geneva. Change made: First…
Ben Kemp
May 28, 2025
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