Class IIa · IIb · III — UK Approved Body routes
Conformity assessment procedures requiring UK Approved Body (UKAB) involvement are in Schedule 3 of the UK MDR 2002 (Part I). The procedures are structured equivalently to Annexes II–VI of the former EU MDD 93/42/EEC. IVD conformity assessment is in Schedule 3 of Part III.
This site provides general information only. Always consult the full Schedule 3 text and your chosen UKAB before selecting a conformity assessment route.
Overview: which routes are available by class?
| Class | Available routes | UKAB role |
|---|---|---|
| Class IIa | Annex II + V, Annex II + VI, Annex III + IV, Annex III + V, Annex III + VI | Audits QMS or examines type specimen; verifies production |
| Class IIb | Annex II + V, Annex II + VI, Annex III + IV, Annex III + V, Annex III + VI | Full QMS audit (preferred); or type examination + production |
| Class III | Annex II only (full QMS + design dossier) | Mandatory full QMS audit + design dossier examination |
| AIMD | Annex II or Annex III + IV/V/VI (Part II Schedule 3) | Full QMS audit or type examination + production |
| IVD List B | Annex V or Annex VI (Part III Schedule 3) | Type examination or full QA |
| IVD List A | Annex IV + VII (Part III Schedule 3) | Design dossier examination + production QA |
| IVD Self-test | Annex IV or Annex V (Part III Schedule 3) | UKAB assessment of self-test-specific requirements |
The conformity assessment annexes explained
Annex II equivalent — Full Quality System
The Full Quality System procedure is the most comprehensive. The UKAB audits the manufacturer's complete QMS — covering design, development, manufacture, final inspection, and post-market activities.
What the UKAB assesses:
- The QMS structure, documentation, and implementation (typically ISO 13485)
- Design controls and design history files
- Risk management integration (ISO 14971)
- Manufacturing process controls
- Post-market surveillance processes
- Complaint handling and vigilance procedures
For Class III devices: Annex II also requires the UKAB to examine the design dossier for each device (or device family) — a detailed subset of the technical file focusing on design inputs, design verification and validation, pre-clinical data, and clinical evaluation. The UKAB issues a separate Design Examination Certificate for each design dossier reviewed.
Certificates issued:
- QMS Certificate (Annex II) — covering the manufacturer's quality system
- Design Examination Certificate (Annex II, Section 4) — for Class III/AIMD, one per device design
Surveillance: The UKAB conducts periodic surveillance audits (typically annually) and unannounced audits to verify continued compliance.
Annex III equivalent — EC Type Examination
The EC Type Examination (now called "Type Examination" in the UK context) involves the UKAB examining a representative specimen of the device — the "type" — rather than auditing the full QMS.
What the UKAB assesses:
- The device specimen itself against the Essential Requirements
- Pre-clinical test reports accompanying the technical documentation
- Clinical evaluation summary
- Labelling and IFU
Certificate issued:
- Type Examination Certificate — valid for a specified period (typically 5 years, renewable)
After type examination: The manufacturer must then ensure that all production conforms to the examined type. This is done through one of:
- Annex IV (Production Quality Assurance) — UKAB audits production QMS and tests final products
- Annex V (Product Quality Assurance) — UKAB audits final inspection and testing
- Annex VI (Production Quality Assurance with design examination) — manufacturer declares products conform to type
Choosing between Annex II and Annex III routes
| Consideration | Annex II (Full QMS) | Annex III (Type Examination) |
|---|---|---|
| Scope | Whole QMS audited | Single device specimen examined |
| Best for | Manufacturers with multiple device lines | Manufacturers with a single or few device types |
| Ongoing obligation | Annual UKAB surveillance of QMS | Production conformance verified separately |
| Class III mandatory? | Yes — Annex II is the only Class III route | Not available for Class III |
| Flexibility for product changes | High — changes reviewed within QMS context | Lower — changes may require new type examination |
| Industry preference | Widely preferred | Less common; increasingly only for simpler device types |
For Class III and AIMDs, Annex II is the only permitted route.
For Class IIa and IIb, manufacturers may choose either route, but Annex II is increasingly the norm as it provides broader UKAB certification coverage across a product family.
The design dossier (Class III and AIMD)
For Class III devices and AIMDs, the UKAB must review a design dossier as part of the Annex II procedure. The design dossier is not the entire technical file — it is a defined subset:
Contents of the design dossier:
- General description of the device and variants
- Design specifications and drawings
- Manufacturing specifications
- Classification rationale
- Essential Requirements checklist with reference to evidence
- Pre-clinical data: biocompatibility, sterilisation validation, electrical safety, mechanical testing
- Risk management file summary (ISO 14971)
- Clinical evaluation report (or performance evaluation for IVDs)
- Post-market surveillance plan
- Proposed labelling and IFU
The UKAB reviews the design dossier, may request additional information or testing, and ultimately issues (or declines to issue) a Design Examination Certificate. This certificate must exist before a Class III device can bear the UKCA mark.
UKAB audit process: what to expect
Application and scoping
- Manufacturer submits application to chosen UKAB with initial documentation
- UKAB reviews scope and qualifications (are they designated for this device type?)
- Contract agreed; timeline established
Document review
- UKAB reviews QMS documentation and/or technical file/design dossier
- Questions and clarification requests issued to manufacturer
- Manufacturer responds; iterative process
On-site audit
- UKAB conducts on-site audit of manufacturing facilities and QMS
- Interviews with staff, review of records, observation of processes
- Non-conformities identified and categorised (major, minor, observation)
Certificate decision
- UKAB reviews all findings
- Manufacturer addresses non-conformities (corrective action plans for majors)
- UKAB issues certificate (or declines with reasons)
Surveillance
- Annual planned surveillance audits
- Unannounced audits (UKAB right to conduct without prior notice)
- Certificate renewal before expiry (typically every 5 years)
Typical timelines: Initial certification for a Class III device with a design dossier review: 6–18 months from application, depending on the complexity of the device, the completeness of the technical file, and UKAB capacity. Class IIa/IIb QMS audits: 3–9 months typically.
UKAB certificates: what they cover
| Certificate type | What it covers | Validity |
|---|---|---|
| QMS Certificate (Annex II) | The manufacturer's quality system for the device scope | Typically 5 years; annual surveillance |
| Design Examination Certificate | A specific device design | Typically 5 years; requires update for significant design changes |
| Type Examination Certificate | A representative device specimen | Typically 5 years; renewable |
Certificates are issued by the UKAB and referenced in the manufacturer's UK Declaration of Conformity. The UKAB's identification number appears alongside the UKCA mark on the device label.
Certificate suspension and withdrawal
A UKAB may suspend a certificate if:
- The manufacturer fails to maintain QMS compliance
- A serious safety issue is identified with the device
- The manufacturer fails to cooperate with surveillance audits
A suspended certificate means the device cannot lawfully bear the UKCA mark and cannot be placed on the GB market.
A UKAB may withdraw a certificate for persistent or serious non-conformity. MHRA is notified of all suspensions and withdrawals.
IVD conformity assessment (List A, List B, Self-test)
IVD conformity assessment under Part III follows the same annex-based structure but with IVD-specific requirements:
| IVD category | Route | Key UKAB role |
|---|---|---|
| List A | Annex IV (Design Examination) + Annex VII (Production QA) | Examines design including performance data; audits production QMS |
| List B | Annex V (Type Examination) or Annex VI (Full QA) | Examines type specimen or audits full QMS |
| Self-test | Annex III/V with self-test assessment | Evaluates lay-use design and performance |
The UKAB must specifically assess analytical and clinical performance data for IVD conformity assessment — not just the QMS and device design.
Related pages
- Conformity assessment — overview
- Class I self-declaration pathway
- UK declaration of conformity
- UKCA marking requirements
- UK Approved Bodies
- Technical documentation overview
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | All conformity assessment procedures (Annexes I–VII equivalent) |
| UK MDR 2002, Part II Schedule 3 | AIMD conformity assessment |
| UK MDR 2002, Part III Schedule 3 | IVD conformity assessment |
| MHRA: UK Approved Bodies list | Current list of designated UKABs and their scope |
| EU MDD 93/42/EEC, Annexes II–VII | Source annexes for Schedule 3 (comparative reference) |