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…
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February 27, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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.
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February 27, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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February 20, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
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Protected: MedTech Europe Sustainable Corporate Governance Working Group – Call for Evidence
February 20, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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February 6, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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
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January 23, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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January 15, 2026 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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…
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December 12, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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.…
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November 13, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory 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
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November 13, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 24 Nov, 3-4 pm CET)
On Monday, 24 Nov 2025 from 15:00 to 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU In Vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute Q&A. Due to…
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November 13, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
MedTech Europe Position Paper 0n the Med Tech Industry views on simplification of EU digital legislation
Dear members, please see attached the MedTech Europe Position paper ‘The medical technology industry’s views on simplification of EU digital legislation'.
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October 31, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EU MIR 7.3.1 update
The European Commission is planning another MIR 7.3.1 form update to make signature optional (as well as improvements in other remaining issues) which should be published soon somewhere in November. They have also extended the transition timeline for the mandatory implementation of the MIR 7.3.1 form for 4 months after the latest update (counting from the latest update to be…
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October 31, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EU CMR Classification of Ethanol under BPR
Dear members, please see below update on the proposed CMR Classification of Ethanol under EU Biocidal Products Regulation. This would impact Northern Ireland as well as the EU, and would impact the use of ethanol as a disinfectant. Background: Ethanol is currently undergoing a parallel evaluation as a biocidal active substance under the Biocidal Product Regulation and for harmonised classification…
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September 25, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Now ‘Live’! Open Letter to EU Health Commissioner Olivér Várhelyi on IVDR and MDR
On 19 September 2025, together with 35 national associations, MedTech Europe has sent an open letter to European Commissioner for Health & Food Safety, Olivér Várhelyi, calling for urgent action to secure the availability of medical technologies for European citizens and health systems.
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September 22, 2025 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EUDAMED onboarding – Commission’s EUDAMED Workshops: 8 Oct, Rome, Italy; 3 Dec, Brussels, Belgium
Registration is open for the new workshops on EUDAMED, organised by DG SANTE, European Commission: 8 October 2025, Rome, Italy 🇮🇹 3 December 2025, Brussels, Belgium 🇧🇪 For in person or online participation, you can register here. The workshop programme and venues are displayed at the workshops page : Audience: economic operators, notified bodies, national authorities, and other stakeholders Content:…
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