Post-Brexit transition timeline
This page covers the transitional arrangements established through the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (SI 2019/791), subsequent statutory instruments, and DHSC/MHRA policy announcements. The transitional position has evolved significantly since 2020 and continues to be updated.
Transitional deadlines are subject to change by Government announcement. The positions described here are current as of May 2026. Always verify the latest position at gov.uk/guidance/regulating-medical-devices-in-the-uk before making regulatory decisions.
Overview
The UK's departure from the EU on 31 January 2020 (with a transition period ending 31 December 2020) created a need to establish a standalone UK regulatory framework for medical devices. Rather than implementing an entirely new framework overnight, the Government has managed the transition through a series of time-limited grace periods and phased deadlines.
The result is a layered set of transitional arrangements that have been extended multiple times — creating both flexibility for industry and complexity for compliance planning.
Key milestones at a glance
| Date | Event |
|---|---|
| 31 January 2020 | UK leaves the EU; transition period begins |
| 31 December 2020 | Transition period ends; UK MDR 2002 (as amended) becomes operative as standalone GB law |
| 1 January 2021 | MHRA becomes sole GB regulator; UKCA mark introduced; MHRA registration required |
| 1 January 2021 | Northern Ireland Protocol takes effect; EU MDR/IVDR apply in NI |
| 1 July 2023 | First major CE marking grace period expires; new extended grace period announced |
| March 2023 | Windsor Framework agreed; replaces Northern Ireland Protocol |
| 30 June 2030 | Current deadline for CE marking acceptance in GB to end |
Phase 1: End of transition period (January 2021)
From 1 January 2021, Great Britain became a separate medical device regulatory jurisdiction:
- MHRA became the sole competent authority for the GB market
- The UKCA mark was introduced as the conformity mark for GB
- MHRA registration became mandatory for manufacturers, UKRPs, and authorised representatives placing devices on the GB market
- Devices already lawfully placed on the GB market before 1 January 2021 could continue to be made available (sell-through of existing stock)
However, from day one, a transitional grace period was established allowing CE marking to continue to be accepted in GB — recognising that industry could not immediately switch to UKCA marking and UKAB certification.
Phase 2: Initial CE marking grace periods (2021–2023)
The initial arrangements accepted CE marking in GB for defined periods:
| Device type | Original CE acceptance deadline |
|---|---|
| Devices CE-marked under MDD / AIMDD / IVDD | Various — to 30 June 2023 |
| Devices CE-marked under EU MDR / EU IVDR | Accepted during their EU certificate validity |
These arrangements were extended and modified multiple times. The complexity of maintaining different deadlines for different device types and directive/regulation sources led to significant industry concern about the pace of UKCA transition.
Phase 3: Major extension — CE marking accepted until 2030
In June 2023, the Government made a significant policy announcement: CE marking would be accepted for medical devices on the GB market until 30 June 2030, subject to certain conditions.
Current position (as of May 2026)
CE marking is accepted on the GB market for devices that:
- Bear a valid CE mark under EU MDR 2017/745, EU IVDR 2017/746, EU MDD 93/42/EEC (for legacy devices under transitional provisions), EU AIMDD 90/385/EEC, or EU IVDD 98/79/EC
- Are lawfully placed on the EU market under those frameworks
- Are accompanied by appropriate documentation (Declaration of Conformity referencing the EU framework)
Manufacturers relying on CE marking for GB access should ensure their EU certificates remain valid and that their documentation reflects the EU framework — not the UK framework.
CE marking acceptance until 2030 is a significant relief for manufacturers. However, 2030 will arrive. Begin UKCA transition planning now — particularly for higher-risk devices requiring UKAB involvement, given current UKAB capacity constraints.
What has not changed
- MHRA registration remains mandatory regardless of whether a manufacturer uses UKCA or CE marking for GB
- The UKRP requirement remains — non-UK manufacturers relying on CE marking still need a UKRP to register with MHRA
- Post-market obligations (vigilance reporting, FSCAs, PMS) remain unchanged regardless of CE/UKCA status
- Northern Ireland rules are unaffected — EU MDR/IVDR still apply there
Phase 4: UKCA — the destination
From 1 July 2030, CE marking will no longer be sufficient for the GB market. Manufacturers will need:
- UKCA marking based on conformity assessment under UK MDR 2002
- For higher-risk devices: a UK Approved Body certificate
- MHRA registration of the device under the UKCA framework
The practical challenge is significant. The number of designated UK Approved Bodies is small compared to the pool of EU Notified Bodies, and UKAB capacity must grow substantially to absorb demand. MHRA and the Government are actively working on UKAB designation expansion.
Northern Ireland — a separate timeline
Northern Ireland's regulatory timeline tracks EU MDR/IVDR milestones, not UK transitional arrangements:
| Milestone | Northern Ireland position |
|---|---|
| 1 January 2021 | Northern Ireland Protocol takes effect; EU MDR/IVDR apply in NI |
| 26 May 2020 (EU MDR) | EU MDR 2017/745 becomes applicable in NI (on the same date as EU) |
| 26 May 2022 (EU IVDR) | EU IVDR 2017/746 becomes applicable for Class D IVDs in NI |
| March 2023 | Windsor Framework agreed — NI Protocol arrangements confirmed |
| EU IVDR rollout (Class C, B, A) | NI follows EU IVDR phased implementation timeline |
The Windsor Framework did not change the fundamental position — NI aligns with EU MDR/IVDR — but it clarified and in some respects simplified the practical application of those rules for GB-to-NI goods movements.
MHRA registration — timeline
MHRA registration has been mandatory since 1 January 2021. Key registration deadlines:
| Entity | Registration required from |
|---|---|
| New manufacturers placing devices on GB market | 1 January 2021 |
| Existing manufacturers already on the GB market | Phased — with grace periods for registration of existing devices |
| UKRPs | From date of appointment |
MHRA has provided guidance on registration via the MHRA Submissions portal and has worked with industry to ensure existing market participants could register without disruption.
MHRA's reform programme — the next framework
Separately from the transitional arrangements, MHRA is developing a new, reformed UK medical device regulatory framework using the powers in the Medical Devices Act 2021. The reform is intended to:
- Modernise UK MDR 2002 to address AI, SaMD, combination products, and reprocessing
- Introduce a more prescriptive clinical evidence framework
- Establish a full UDI system
- Strengthen post-market surveillance requirements
- Clarify the UKRP and economic operator framework
MHRA has published several consultation documents (2021, 2022) and a response to the consultation setting out its intended direction. Implementation will be by statutory instrument — with timelines to be announced.
The reformed framework may affect transitional deadlines and UKCA requirements. Monitor MHRA consultations and the What's New section for updates.
Summary: what manufacturers should do now
| Priority | Action |
|---|---|
| Immediate | Register with MHRA via the Submissions portal if not already done |
| Immediate | Appoint a UKRP if your manufacturing entity is not established in Great Britain |
| Short-term | Verify that CE certificates remain valid and cover your GB-marketed devices |
| Medium-term | Identify which UK Approved Body you will use for UKCA certification |
| Medium-term | Begin technical file gap analysis against UK MDR 2002 Essential Requirements |
| Long-term | Plan UKCA transition before 2030 deadline — do not leave it to the last moment |
| Northern Ireland | Ensure EU MDR/IVDR compliance is maintained for NI market access |
Related pages
- Great Britain vs Northern Ireland
- UKCA marking requirements
- UK Approved Bodies
- MHRA registration
- What's New
- Northern Ireland & Windsor Framework
Official references
| Reference | Description |
|---|---|
| SI 2019/791 | Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 |
| Medical Devices Act 2021 | Powers for regulatory reform |
| MHRA: Regulating medical devices in the UK | Current MHRA position on transitional arrangements |
| DHSC: UKCA marking — June 2023 announcement | Extension of CE marking acceptance to 30 June 2030 |
| Windsor Framework (March 2023) | Agreement governing NI regulatory position |
| MHRA: Future regulation of medical devices | Consultation responses and reform programme |