UKCA / CE transitional deadline tracker
note
This tracker reflects the regulatory position as of May 2026. Deadlines are subject to change by Government announcement.
Current position summary
| Deadline | Status (May 2026) |
|---|---|
| CE marking accepted in GB | ✅ Accepted — until 30 June 2030 |
| MHRA registration mandatory | ✅ Required now — no grace period for new devices |
| UKRP appointment (non-UK manufacturers) | ✅ Required now |
| UKCA marking required | ⏳ From 1 July 2030 |
| EU IVDR in NI (Class D) | ✅ In force |
| EU IVDR in NI (Class C) | ✅ In force (from May 2025) |
| EU IVDR in NI (Class B, A) | ⏳ Follow EU IVDR transition schedule |
Key dates
| Date | Event |
|---|---|
| 1 January 2021 | UK MDR 2002 (as amended) operative as standalone GB law; MHRA registration mandatory |
| 1 January 2021 | Northern Ireland Protocol in effect; EU MDR/IVDR apply in NI |
| March 2023 | Windsor Framework agreed |
| June 2023 | Government announces CE marking accepted in GB until 30 June 2030 |
| 30 June 2030 | CE marking transitional acceptance in GB ends — UKCA required |
What manufacturers should do now (May 2026)
| Priority | Action |
|---|---|
| Immediate | Ensure MHRA registration is complete and current |
| Immediate | Appoint UKRP if not UK-established |
| Short-term | Verify EU certificates remain valid and cover GB-marketed devices |
| Medium-term | Identify UKAB and begin engagement for UKCA transition |
| Medium-term | Conduct gap analysis of technical files against UK MDR 2002 ERs |
| By 2028 | Target UKAB application submission for Class IIb/III devices |
| By 2030 | Complete UKCA certification for all GB-marketed higher-risk devices |
Official references
| Reference | Description |
|---|---|
| DHSC: UKCA marking | Gov.uk UKCA marking guidance |
| MHRA: CE marking transitional acceptance | Current position document |