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MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Joint industry statement following EU–Switzerland agreement package

Following the recent signature of the EU–Switzerland agreement package, MedTech Europe, Swiss Medtech and SVDI have issued a joint statement welcoming the signature and highlighting the importance of updating the medical devices chapter of the Mutual Recognition Agreement (MRA) for the medical technology sector. As many of you will know, the MRA enables mutual recognition of conformity assessment procedures, allowing…
admin
March 19, 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
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
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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe – Clinical evidence requirements ebook fourth edition published

Dear Members, if you’re not already aware, MedTech Europe published the 4th Edition of the Clinical Evidence Guidance available to download from: Clinical Evidence Requirements for CE certification - MedTech Europe.
Ben Kemp
February 27, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MTE- EU-US Tariffs – Situation Update

An update from MedTech Europe on the current US-EU tariffs situation. Last Friday, the Supreme Court in the US, has ruled (6:3) against president Trump’s imposition of tariffs pursuant to the International Emergency Economic Powers Act (IEEPA) 24-1287 Learning Resources, Inc. v. Trump (02/20/2026) The ruling has invalidated the legal basis for the US’ broad, sudden tariffs such as the…
Ben Kemp
February 27, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EC Call for Feedback on Draft DA on Waste Framework Directive

Please be kindly informed that the European Commission has published a Call for Feedback on a draft Delegated Act establishing rules on the calculation and verification of the weight of materials lost and not recycled after a waste sorting operation. The draft Delegated Act is pursuant to Article 11a(10) of the Waste Framework Directive. Next steps: The Call for Feedback…
Ben Kemp
February 20, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED VGL module implementation timeline

The published EUDAMED implementation timeline indicates Q2 2027 as the start of the mandatory use of the VGL module (no voluntary use foreseen – see copied below). Please refer to this official source of EUDAMED implementation timelines at the European Commission’s EUDAMED website: https://health.ec.europa.eu/medical-devices-eudamed/overview_en  
Ben Kemp
February 6, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe update on EUDAMED progress

Mandatory use of the first four EUDAMED modules (Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance) starts as of 28 May 2026 EUDAMED PLG v3.22 released on 12 December: This release includes updates reflecting feedback from the VGL CA Board’s coordinated testing. According to the release notes, it is now possible to change the referenced device in…
Ben Kemp
January 23, 2026
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