UK Medical Device Transition: UKCA, CE Acceptance and Post-Market Rules
Plan each device's Great Britain route before CE acceptance ends, and run post-market surveillance to the June 2025 rules.
In Short
- CE accepted to 2028 or 2030.
- New PMS rules since 16 Jun 2025.
- Northern Ireland differs.
Great Britain regulates medical devices under the Medical Devices Regulations 2002 (SI 2002/618), as amended. Regulation 1ZA sets when the provisions accepting CE-marked devices cease: 30 June 2028 for devices under the older EU directives, and 30 June 2030 for devices under the EU MDR or IVDR. SI 2024/1368 added new post-market surveillance requirements from 16 June 2025. Northern Ireland follows different rules. Orientation, not legal advice. Sources checked 4 Oct 2026.
How long CE marking is accepted in Great Britain
Regulation 1ZA of SI 2002/618 says regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028, and regulations 19C, 44ZA and 44ZB at 23:59 on 30 June 2030, subject to conditions. In practice, devices CE marked under the older EU directives can rely on acceptance until 30 June 2028 at most, and devices under the EU MDR or IVDR until 30 June 2030, if the conditions continue to be met.
Great Britain Acceptance of CE-Marked Devices
- 16 Jun 2025New post-market surveillance requirements in force (SI 2024/1368)
- 30 Jun 2028Regulations 19B and 30A cease: older EU directive devices
- 30 Jun 2030Regulations 19C, 44ZA and 44ZB cease: EU MDR and IVDR devices
More on how long CE marking is accepted in Great Britain
Read regulations 19B and 19C in full for those conditions.
What UKCA marking requires
UKCA marking shows conformity with the Great Britain regime under the 2002 Regulations. The device must meet the applicable essential requirements and go through the right conformity assessment before the mark is affixed.
More on what UKCA marking requires
MHRA registration and UK responsible person provisions were not opened for this guide; confirm them with the current text and MHRA guidance. Plan which devices will move to UKCA before the CE acceptance dates, how long a UK approved body needs, and whether international reliance routes proposed by the MHRA apply; those routes were not opened for this guide.
Post-market surveillance from 16 June 2025
SI 2024/1368, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, was made on 16 December 2024 and came into force on 16 June 2025. It adds requirements for a post-market surveillance system and plan, reporting of serious incidents and field safety corrective actions, trend reporting and periodic summary reports.
More on post-market surveillance from 16 June 2025
The revised legislation.gov.uk text still lists outstanding changes not yet applied, so read the amending instrument itself alongside the consolidated text.
Organise one device record for both markets
Many manufacturers sell the same device in the EU and Great Britain during the transition. Keep one record per device and version that shows its marking route in each market, certificate and expiry, responsible person, registration, technical documentation version and labelling.
Worked example: device register (extract)
| Device | GB route today | Plan |
|---|---|---|
| MD-101 infusion set | CE (EU MDR certificate) | Rely to 2030; UKCA review 2027 |
| MD-207 wound dressing | CE (older directive) | UKCA application before 2028 |
| MD-330 test kit | UKCA | Keep PMS plan current |
- MD-101 infusion set
- GB route today
- CE (EU MDR certificate)
- Plan
- Rely to 2030; UKCA review 2027
- MD-207 wound dressing
- GB route today
- CE (older directive)
- Plan
- UKCA application before 2028
- MD-330 test kit
- GB route today
- UKCA
- Plan
- Keep PMS plan current
More on organise one device record for both markets
Track the conditions for continued CE acceptance as dated tasks. When a design or supplier change happens, record whether it affects either route, because a significant change can end reliance on an existing certificate.
Where V5 fits and where people decide
V5 keeps device documentation, change control, complaints, CAPA and supplier records linked, with revision history and electronic sign-off. It does not decide conformity, classify incidents or report to the MHRA.
More on where V5 fits and where people decide
Your regulatory, quality and UK responsible person decide the marking route, whether a change is significant and whether an event is reportable. Use the complaint and trend records as evidence for your post-market surveillance plan, reviewed by people.
Questions
Until when does Great Britain accept CE-marked devices?
Under regulation 1ZA, until 30 June 2028 for older directive devices and 30 June 2030 for EU MDR or IVDR devices, subject to conditions.
When did the new UK post-market surveillance rules start?
SI 2024/1368 came into force on 16 June 2025, adding post-market surveillance, incident and trend reporting requirements.
Is the consolidated legislation fully up to date?
Not yet. legislation.gov.uk lists outstanding changes from SI 2024/1368, so read the amending instrument alongside the consolidated text.
Does this guide cover Northern Ireland?
No. Northern Ireland follows different arrangements; check MHRA guidance for devices placed on the Northern Ireland market.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
- UK Medical Device Regulatory Readiness Guide (GB and NI)
Predetermined Change Control Plans (21 U.S.C. 360e-4) for Medical Devices
Australia Medical Device Regulatory Readiness Guide
Brazil medical device regulatory readiness guide (ANVISA)
Canada Medical Devices Regulations (SOR/98-282) Readiness
China Medical Device Regulatory Readiness Guide 2026