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MedTech Europe Updates Regulatory Affairs Newsletter

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

For input by 29/8: ECHA RAC Talc Opinion/Classification Carcinogenic 1B

Dear members, please see below call for feedback regarding the classification of ‘Talc’ as Class 1B Carcinogen. The focus is on Medial devices. I’m not aware of any IVD devices that utilise ‘Talc’, but if your impacted please contact me via regulatory@bivda.org.uk We are writing to inform you that recently, the European Chemical Agency’s (ECHA) Risk Assessment Committee (RAC) published…
Ben Kemp
August 22, 2025
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PUBLISHED – MedTech Europe reflection paper on Sampling under IVDR

Dear Members, MedTech Europe have published the reflection paper on Notified Body Sampling of technical files under the IVDR. This is part of the work that MedTech Europe is under taking to look at reducing administrative burden as part of the review of the implementation of the IVDR. You can find the published document on MedTech Europe website here: https://www.medtecheurope.org/news-and-events/news/sampling-under-in-vitro-diagnostics-regulation-medtech-europe-proposal-for-a-more-risk-based-approach/…
Ben Kemp
August 4, 2025
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New Publication – Orphan IVDs – TEAM-NB

Dear Members, please see below update from MedTech Europe. This publication from Team NB outlines it’s position on Orphan IVDs under IVDR, which would also apply to Northern Ireland. It describes the suggested approach that the notified bodies would take when reviewing IVD that qualify as ‘orphan’ IVDs. There is a further meeting planned with the EC regarding the issue…
Ben Kemp
August 4, 2025
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Invitation to Participate in EU4MEDTECH Questionnaire on Innovative and High-Risk MDs and IVDs

On behalf of the EU4MEDTECH project, you are kindly invited to participate in a short questionnaire designed to better understand the current practices, challenges, and digital needs of various stakeholder groups involved in the evaluation of innovative and high-risk medical devices (MDs) and in vitro diagnostic devices (IVDs). This initiative which is part of the EU4MEDTECH project, which aims to…
Ben Kemp
July 30, 2025
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Feedback needed on technical implementation issues with EU MIR 7.3.1

Please see below request for feedback regarding implementation issues with the EU MIR 7.3.1. I would need feedback by midday Monday 30th June please, to regulatory@bivda.org.uk Dear All, The European Commission has reached out to us with a request to provide feedback on the state of play of IT implementation of MIR 7.3.1 PDF file. The European Commission has received…
Ben Kemp
June 26, 2025
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For approval by 8 July: RoHS renewal requests (Batch 1)

Dear members, please see the below update on progress with EU RoHS renewals proposed by the Umbrella project. Let me have any objections to MedTech Europe Co-Signing these exemption requests by CoB  4th July. Note that if successful these will apply to Northern Ireland, however to obtain similar exemptions for GB, separate applications under GB RoHS are required and there…
Ben Kemp
June 26, 2025
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For information: OSOA provisional agreement reached by Council/Parliament

Dear members, MedTech Europe update on the EU progress with the proposed One Substance One Assessment (OSOA) legislation. Dear members, I hope you are all well. We are writing to update you on the latest developments on the ‘One Substance, One Assessment’ (OSOA) package of legislative proposals, including targeted amendments to MDR, RoHS, and the proposal for a new chemicals…
Ben Kemp
June 18, 2025
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Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe. Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from…
Ben Kemp
June 9, 2025
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New educational guide for the use of the European Medical Device Nomenclature (EMDN)

Manufacturers operating under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are required to utilise the European Medical Device Nomenclature (EMDN) for regulatory submissions, device registration in EUDAMED, and sampling. To support consistent and compliant application, MedTech Europe released a practical guide to the use of the European Medical Device Nomenclature which: Assists in the…
Ben Kemp
May 28, 2025
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IHI Call 11

MedTech Europe are promoting IHI Call 11. Since we rejoined Horizon Europe UK businesses can engage in the EU IHI process. IHI matches academics with industry and matches EU funding with industry funding/resource to work on joint projects to improve health, and tackle problem areas. Just published – Innovative Health Initiative draft topic texts for Call 11 - MedTech Europe
Ben Kemp
May 15, 2025
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