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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
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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
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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
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CLSI Standard PRE06 – Evaluation of External Transport Systems

Dear Members, CLSI have published a new standard for evaluation of external transport systems. This is a laboratory focused standard. PRE06 | Evaluation of External Transport Systems Abstract CLSI PRE06—Evaluation of External Transport Systems describes processes for evaluating an external transport system. Specimens are commonly transported from external, off-site locations to the laboratory, where they are eventually examined. The system…
Ben Kemp
March 5, 2026
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Your latest One IPO Patent Service update!

The One IPO Patent Service is launching on 31 March 2026. Here are the latest updates to keep our patent customers informed: What to expect when the One IPO Patent Service launches Today we have published an update on what our patent customers can expect as we approach the launch of the new service on 31 March. Find out more:…
Ben Kemp
March 5, 2026
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MHRA Updates: WC 2nd March

Regulation as an Enabler of Innovation: A Regional Perspective Page summary: By Richard Stubbs Change made: First published. Time updated: 11:30am, 24 February 2026 MHRA Safety Roundup: February 2026 Page summary: Summary of the latest safety advice for medicines and medical device users Change made: First published. Time updated: 11:12am, 25 February 2026 If you have any questions about the…
Ben Kemp
March 5, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates: WC 2nd March

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Removed import authorisation ‘EU non-harmonised animal by-products (IMP/GEN/2025/08)’ and replaced it with a ‘EU non-harmonised animal by-products (IMP/GEN/2026/01)’ authorisation. Also removed the…
Ben Kemp
March 5, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates: WC 2nd March

General licences and authorisations to import live animals or animal products Page summary: Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products. Change made: Removed import authorisation ‘EU non-harmonised animal by-products (IMP/GEN/2025/08)’ and replaced it with a ‘EU non-harmonised animal by-products (IMP/GEN/2026/01)’ authorisation. Also removed the…
Ben Kemp
March 5, 2026
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