United Kingdom medical device registration timeline
Source-linked clocksMedicines and Healthcare products Regulatory Agency (MHRA) review clocks and end-to-end planning ranges, using the 4-class (I, IIa, IIb, III) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(Self-declaration (no approved body)) UK MDR 2002 Part II: Class I devices that are not sterile and have no measuring function are self-declared, so no approved body or MHRA review of the file takes place and no review clock runs | 0 days | 0.5-1 months | 2-3 weeks | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesUnited Kingdom Medical Device Registration Process
Step-by-step MHRA registration process. Total estimated timeline: 0.5-1 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by MHRA. Appoint a UK Responsible Person.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MHRA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMHRA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 daysIn-depth technical assessment of device safety and performance. MHRA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MHRA issues United Kingdom market authorization certificate.
EU CE marks accepted during transition period
Eligibility: Class III & IIb implantable: until Dec 2027, Other classes: until Jun 2028, MDR/IVDR compliant: until Jun 2030
Stand-alone route giving a Certificate of International Reliance to devices already authorised by the FDA, Health Canada or the TGA, without UKCA marking; the EU is deliberately excluded pending the separate CE-recognition decision
Eligibility: Draft Medical Devices (Amendment) Regulations 2026, WTO-notified 8 May 2026, Route 1 lowest-risk: self-declaration and registration only, Routes 2 and 3: certificate from a UK approved body first, Anticipated in force mid-2028
- UK Responsible Person (for non-UK manufacturers)
- UKCA marking or CE marking (during transition)
- UK Approved Body certification (for UKCA)
- MHRA registration
- Clinical investigations: at least 60 days prior written notice to the Secretary of State before supplying a device (UK MDR 2002 reg. 16(1) for devices, reg. 29(1) for IVDs); the investigation may begin once 60 days pass without an objection notice under reg. 16(4), or earlier if the MHRA gives a no-objection notice under reg. 16(5)
- Devices incorporating an ancillary medicinal substance: the approved body must consult the Secretary of State, whose scientific opinion is drawn up within 210 days of receipt of valid documentation, and the approved body may not certify against an unfavourable opinion
- Post-market surveillance under the 2024 amendment: serious incidents reported within 15 days, serious public-health threats within 2 days, and PMS or FSCA documentation supplied within 3 working days of an MHRA request
- Northern Ireland custom-made devices: register within 28 days of being made available on the NI market
- The Draft Medical Devices (Amendment) Regulations 2026, notified to the WTO on 8 May 2026, would add an international reliance route recognising US, Canadian and Australian approvals; it is a draft instrument only, expected to be adopted in December 2026 and in force from June 2027, so it fixes no clock today
Reviewed 2026-08-29. End-to-end totals remain planning estimates.