Upcoming changes & reform tracker
Known upcoming changes
UKCA marking deadline — 30 June 2030
From 1 July 2030, CE marking will no longer be accepted as the sole conformity basis for the GB market. UKCA marking will be required. Manufacturers should begin UKCA transition planning well in advance.
MHRA reform programme — new UK framework
MHRA intends to implement a reformed UK medical device regulatory framework using the Medical Devices Act 2021 enabling powers. Expected elements include:
- More prescriptive clinical evidence requirements (moving closer to EU MDR standards)
- A full UK UDI system with a dedicated database
- Strengthened PMS and PSUR requirements
- Clearer economic operator (UKRP, importer, distributor) obligations
- Possible IVD reclassification (moving toward IVDR-style Class A/B/C/D)
Timelines for implementation have not been confirmed. Monitor MHRA announcements.
UK UDI implementation
MHRA is phasing in UDI requirements. Labelling and database requirements are being implemented by device class. Check MHRA's UDI guidance for current deadlines.
EU IVDR transition in NI
The EU IVDR 2017/746 continues its phased application in Northern Ireland. Manufacturers of IVDs for the NI market should track IVDR transition milestones by class.
Official references
| Reference | Description |
|---|---|
| MHRA: Future regulation of medical devices | Reform programme information |
| MHRA: UDI guidance | UDI implementation timeline |
| DHSC: UKCA marking | UKCA policy and 2030 deadline |