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Regulatory Affairs Newsletter Archive

Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers

Dear Members, IMDRF have issued Industry guidance on the considerations for the selection of IMDRF Adverse Event Terminology  N86: Final 2026 It includes examples of which 8, 12 and 18 are specific to IVDs. Considerations for the selection of IMDRF Adverse Event Terminology – A Guide for Industry Partners and Healthcare Providers View article...
Ben Kemp
March 5, 2026
Now Published: CLSI C65 | Biochemical Tumor Markers Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Now Published: CLSI C65 | Biochemical Tumor Markers

New Publication! Strengthen Tumor Market Testing with CLSI C65   Biochemical tumor marker plays a critical role in diagnosis, monitoring, and clinical decision making. With increasing pressure on laboratories to ensure accuracy and consistency across preexamination, examination, and postexamination processes, the new CLSI C65 standard provides the guidance needed to reduce risk and improve confidence in patient results.   Practical…
Ben Kemp
March 2, 2026
Team NB – Position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Team NB – Position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment

Dear Members, Team NB have published their position paper on the demonstration of safety and performance for combinational Use of Reagent Devices with other Equipment Team-NB Position Paper on Demonstration of Safety and Performance for Combinatorial Use of Reagent Devices with other devices or Equipment - team-nb
Ben Kemp
March 2, 2026
Register medical devices to place on the market Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Register medical devices to place on the market

Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Changes to registration requirements for Northern Ireland effective 28 May 2026Updated Fees implementation guidance; clarification concerning fee waivers and new section for Northern Ireland feesIVDs undergoing performance evaluation; minor updates…
Ben Kemp
February 27, 2026
MedTech Europe – EUDAMED MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe – EUDAMED

The EC currently has an open survey on EUDAMED preparedness. MedTech Europe have highlighted the absence of adequate documents in the following areas. If you would like to respond to the EC survey, please see the link below, and the list of items that MedTech Europe has identified, but could do with other survey respondents also highlighting. Should you wish…
Ben Kemp
February 27, 2026
New resources on market actions and minor PRAC updates Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New resources on market actions and minor PRAC updates

Dear Members, TGA Australia have issued New resources on market actions and minor PRAC updates We have published a new FAQ and Guidance page on the use of legislative powers related to recalls and other market actions. View article...
Ben Kemp
February 27, 2026
Use of legislative powers related to recalls and other market actions Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Use of legislative powers related to recalls and other market actions

Dear Members, TGA Australia have issued an update on use of legislative powers related to recalls and other market actions Guidance to help sponsors understand the legislative powers the TGA can use relating to market actions. View article...
Ben Kemp
February 27, 2026