The session was introduced with a summary of the EU-UK Trade and Cooperation Agreement (TCA) which provides the basis for how the UK is operating post-Brexit. Notably, this agreement does not include mutual recognition of medical devices or IVDs, which is why the UK is now developing our own regulatory regime. The agreement entered into force on 1 April 2021.
A summary was given on where we are with the MHRA consultation, and that the planned focus groups will begin on Monday 4 April. The response to the consultation was expected in March, but has not yet been published.
ABHI and BIVDA then gave an update on how they are prioritising different aspects of the consultation, linking to the main key topics identified by the BIVDA membership:
- Economic operator requirements
- Clinical evidence
- PMS and PMPF
- IVD classification
- Mutual recognition
- Transitional arrangements
There was lots of interesting discussions and points of view raised, but the general consensus was that those on the call are keen to align to a regulatory structure that allows for an efficient route to market. As expected, there was a lot of concern around the proposed MHRA timescales and there not being sufficient time, something BIVDA is continuing to raise with MHRA.
MedTech Europe did indicate they could be keen to do an updated workshop in the near future once the MHRA consultation has been published, or when more details are known about the regulatory changes. BIVDA will continue to feed into these discussions.