MedTech Europe have responded to the EU Carbon Border Adjustment Mechanism consultation. The current position is that this would impact not only importers of in scope materials, but also some products made of these energy intensive materials which includes Aluminium, Iron, Steel, Glass and Ceramics, if they are not produced as Net Zero products. At this current time, the EU…
Ben KempAugust 28, 2025
Dear members, please see below update regarding submission for EU RoHS Annex III exemption packs 4(a)-I and 4(f)-IV regarding lamps, specifically mercury containing lamps used because they emit light in the UV wavelengths. The joint submissions have been made under the Umbrella project and via Lighting Europe. These will also apply in Northern Ireland. Please note that members interested in…
Ben KempAugust 28, 2025
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 KempAugust 22, 2025
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 KempAugust 4, 2025
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 KempAugust 4, 2025
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 KempJuly 30, 2025
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 KempJune 26, 2025
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 KempJune 26, 2025
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 KempJune 18, 2025