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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

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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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…
Ben Kemp
November 13, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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…
Ben Kemp
October 31, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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…
Ben Kemp
October 31, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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.
Ben Kemp
September 25, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory 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:…
Ben Kemp
September 22, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

RoHS Updated Delegated Acts – Annex III Exemptions 6-7

The draft delegated acts for the RoHS Annex III exemptions series 6-7, have now been sent to the European Parliament and Council for scrutiny. This applies to the EU and NI. Contents:  These draft delegated acts have been updated to take onboard some of the recommendations of MedTech Europe and the Umbrella Project, also as discussed directly with the Commission…
Ben Kemp
September 12, 2025
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