Trade associations representing Medical Devices (MD) and In-Vitro Diagnostics (IVD) manufacturers in the UK and EU have written a letter to the leaders of the UK and EU Brexit negotiating teams. Associations have identified five critical factors that should be included in a post-Brexit agreement to ensure continuity in patient access to safe and effective medical technologies, as it has been since the publication of Medical devices legislation 25 years ago.
These factors are:
- The UK should remain an active member in the current CE marking regime and ensure a complete adoption of the new MD and IVD regulation (in May 2020 and May 2022 respectively).
- The UK Notified Bodies should remain European designated.
- UK-based manufacturers and Authorised Representatives should be considered as “EU-based”.
- MHRA should participate in the new Medical Devices Coordination Group (MDCG).
- The UK should continue having access to the new Eudamed database.
Another important point according to the associations would be to limit regulatory and administrative barriers for the movement of goods between the UK and the EU.
For all these reasons, they ask for a transition period for the implementation of the necessary measures, and intend to continue their engagement in the Brexit negotiations.