Skip to main content
search
All Posts By

Ben Kemp

Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC Updates: WC 8th March

Changes to NICE regulations: cost-effectiveness threshold Page summary: Consultation seeking views on proposals to give ministers limited powers to direct the National Institute for Health and Care Excellence (NICE) in setting the standard cost-effectiveness threshold. Change made: Added the government response to the consultation. Time updated: 4:58pm, 3 March 2026 England Rare Diseases Action Plan 2026 Page summary: The fifth…
Ben Kemp
March 13, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

HRA Now – New process to make it easier to set up research involving health and social care staff as participants

What: we are introducing a new proportionate process to make it easier to set up research involving health and social care staff as participants in the UK Who: sponsors, researchers, NHS and HSC organisations in England, Wales, Scotland and Northern Ireland When: the new process comes into effect on Tuesday 10 March 2026 We are introducing a new process to help streamline the application…
Ben Kemp
March 13, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For Review by 11 March: Weekly ECHA Substance Evaluations

Dear members, please see below MedTech Europe update, if your impacted please let me know at regulatory@bivda.org.uk We would like to inform you about the latest chemical developments at ECHA and kindly ask you to indicate if any of the following impact your company by 11 March. Please note that the substances highlighted in yellow are the ones previously identified as…
Ben Kemp
March 9, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Medical Devices (Fees Amendment) Regulations 2026

Dear members, as previously discussed regarding the changes to the MHRA fees, the proposal has now been adopted in law, amending the UK MDR 2002 (as amended) and the Medical Device (Northern Ireland Protocol) Regulations 2021 The Medical Devices (Fees Amendment) Regulations 2026 These Regulations make amendments to the Medical Devices Regulations 2002 (“the 2002 Regulations”) and the Medical Devices…
Ben Kemp
March 9, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

UPDATED! IMDRF Adverse Event Terminology 2026

On 3 March 2026 the International Medical Device Regulators Forum (IMDRF) has updated the Adverse Event Terminology . The updated codes are available on their website Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes
Ben Kemp
March 9, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IMDRF – Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation

Dear Members, please be advised that IMDRF have published their consultation on Clinical Evidence for IVD Medical Devices – Definitions and Principles of Performance Evaluation. View article...
Ben Kemp
March 9, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Team PRRC EU AI Act Webinar

Team PRRC are running a webinar on the EU AI act and its impact on the MDR/IVDR framework: 🚨 New Webinar Alert – Organized by TEAM-PRRC 🚨 Navigating the EU AI Act: Practical Compliance Implications for PRRCs Artificial Intelligence is no longer a future topic for MedTech. It is now a regulated reality. With the entry into force of the EU AI…
Ben Kemp
March 9, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA: Good clinical practice for clinical trials

Dear Members, please see update MHRA guidance page on Good Clinical Practice for clinical trials. This is focused on medicinal product trials, however it maybe applicable to laboratories supporting clinical trials. Medicines: good practice Good clinical practice for clinical trials Page summary: How to show the MHRA you’re meeting good clinical practice (GCP) standards and what to expect from an…
Ben Kemp
March 5, 2026
Close Menu