Skip to main content
search
Category

MedTech Europe Updates Regulatory Affairs Newsletter

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

For review by 21 January: Weekly ECHA Substance Evaluations

Dear members, please see below list of chemicals flagged as under review for EU CLP by ECHA. MedTech Europe have highlighted the chemicals in yellow as potentially being found in MD/IVDs. Please let me know at regulatory@bivda.org.uk if any of these impact your products. CLP Intention to harmonise classification and labelling – link here:   Pyroxsulam (EC -, CAS 422556-08-9) Proposal…
Ben Kemp
January 15, 2026
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU CLP ‘stop the clock’ amendment

Dear Members, please see below update impacting EU CLP, that will also apply in Northern Ireland impacting Chemicals Classification, Labelling and Packaging requirements. With this email, we would like to follow up on the email below and inform you that the targeted amendment to the CLP Regulation—commonly referred to as the “stop-the-clock” measure—was published yesterday in the EU Official Journal.…
Ben Kemp
December 12, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Position paper on Digital Label for importer and authorised representative published as a joint paper

Dear Members, please see below link to the MedTech Europe Position Paper on digital labelling. This is part of the ongoing advocacy to promote the adoption digital labelling as part of the reforms to the IVDR/MDR. Digital label for authorised representative and importer - MedTech Europe
Ben Kemp
November 13, 2025
Close Menu