Please note that the EU has launched a follow up focused consultation on the streamlining of the EU MDR and IVDR.
This is a more focused consultation following on from the previous consultation, and the EC are not intending to conduct a full review of the implementation of the MDR and IVDR. MedTech Europe are very focused on these consultations, and have developed position papers looking to reduce administrative burden which will be the basis of the MTE response to the consultation.
These consultations are important, because they not only directly apply to Northern Ireland, but will remain critical to CE marked product on the GB market.
Interested stakeholders – including manufacturers, clinicians, notified bodies, and patient groups – are invited to submit their views by 11:59pm CEST on Sunday, 6th October 2025 via the European Commission’s ‘Have Your Say’ portal.
If you want BIVDA to respond, please provide your feedback to the consultation to regulatory@bivda.org.uk
