UKAB certificates
See the official sources listed in the references table at the bottom of this page.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
Types of certificates issued by UK Approved Bodies — QMS certificates, Design Examination certificates, Type Examination certificates, their validity period, and what suspension or withdrawal means.
Certificate types
| Certificate type | What it covers | When issued |
|---|---|---|
| QMS Certificate (Annex II) | The manufacturer's full quality management system for the device scope | After full QMS audit (Class IIa, IIb, III, AIMD) |
| Design Examination Certificate | A specific device design (Class III and AIMD only) | After design dossier review |
| Type Examination Certificate (Annex III) | A representative specimen of the device | After type examination (Class IIa, IIb) |
| IVD Certificates | IVD-specific assessment results (List A design dossier, List B type examination) | Per IVD Part III procedures |
Certificate validity
Certificates are typically valid for 5 years, subject to:
- Annual surveillance audits maintaining compliance
- No significant non-conformities identified during surveillance
- MHRA's continued designation of the issuing UKAB
Certificate renewal
Before expiry, the manufacturer must initiate a renewal assessment. Renewal involves a full reassessment by the UKAB — it is not automatic.
Certificate suspension
A UKAB may suspend a certificate when:
- The manufacturer fails to maintain QMS compliance
- A serious safety issue arises with the device
- The manufacturer fails to cooperate with surveillance audits
During suspension, the device cannot lawfully bear the UKCA mark and cannot be placed on the GB market.
Certificate withdrawal
Persistent or serious non-conformity results in certificate withdrawal. The manufacturer must cease placing the device on the GB market. MHRA is notified of all suspensions and withdrawals.
UKAB identification number on the device
When a device requires UKAB assessment, the UKAB's identification number must appear alongside the UKCA mark on the device label.
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Certificate requirements |
| MHRA: UK Approved Bodies | UKAB certificate oversight |