ABHI Member Briefing: MHRA Proposals on CE Marking and Regulatory Reform

Venue: Online.

Start: Thursday 31 Jul 2025 11:00

End: Thursday 31 Jul 2025 11:30

Members are invited to join us for an update on the MHRA’s latest regulatory reform proposals, including the intention to consult on indefinite recognition of CE marking in Great Britain.

We will also cover other key elements of the announcement, including:

• New international reliance routes with trusted regulators (FDA, Health Canada, TGA).
• A refocus of the UKCA route on first-in-market innovation, including AI.
• The removal of physical UKCA marking once UDI is in place.
• A more risk-based approach for Class B IVDs.

The session will provide an overview of what the proposals mean for members, and outline ABHI’s engagement plans in the lead-up to consultation.

Register here.