Conformity Assessment Overview
What is Conformity Assessment?
Conformity assessment is the systematic examination process used to demonstrate that a medical device meets the Essential Principles of Safety and Performance set out in the Medical Device Regulations 2012.
MDA requires evidence of conformity assessment as part of the device registration dossier for all Class B, C, and D devices (and for sterile Class A devices).
Essential Principles
The Essential Principles are derived from GHTF/SG3 and require that medical devices:
- Are safe and effective for their intended purpose
- Do not unnecessarily compromise the safety of patients, operators, or third parties
- Meet the intended performance claimed by the manufacturer
- Are designed and manufactured to minimise risk
- Maintain performance throughout their expected lifetime
Manufacturers demonstrate conformity to Essential Principles primarily through:
- Compliance with applicable harmonised or MDA-recognised or harmonised (such as ISO 13485 for QMS, ISO 14971 for risk management, and device-specific standards) standards
- Other means of conformity (clinical data, testing, risk analysis) where standards do not fully cover the Essential Principle
Conformity Assessment Routes
Route 1 — Full Quality Assurance System (QMS)
- Most common route for all device classes
- Manufacturer holds a current ISO 13485 certificate from a MDA-recognised Certification Body (CB)
- QMS covers design (for Class C/D), manufacture, and post-market activities
- Supplemented by technical documentation demonstrating product compliance
Route 2 — Type Examination + QMS
Third-party examination by a MDA-recognised CAB of a representative device specimen Assessment of technical documentation against Essential Principles Typically used when QMS certification alone is insufficient to demonstrate conformity, particularly for novel Class C and D applications Manufacturer must maintain a current ISO 13485 certificate in parallel
Route 3 — Self-Declaration (Class A only)
- Manufacturer self-declares conformity to Essential Principles
- No independent third-party assessment required
- Still requires documented evidence supporting the self-declaration
- See Class A — Notification
Role of Conformity Assessment Bodies (CABs)
For Class C and D devices, MDA-recognised CABs play a formal role:
- Review technical documentation against Essential Principles
- Issue Technical Documentation Assessment Reports
- Are independent of the manufacturer
- MDA maintains a list of recognised CABs on its website
CABs recognised by MDA include international notified bodies (e.g., BSI, TÜV SÜD, SGS, Intertek) and regional testing organisations. A current list of MDA-recognised CABs is available on the MDA website and should be consulted before submitting a dossier.
Standards in Conformity Assessment
Compliance with applicable recognised standards creates a presumption of conformity with the corresponding Essential Principles. See Recognised Standards for the full standards list.
Summary by Device Class
| Class | QMS Required | CAB Review | Self-Declaration |
|---|---|---|---|
| A | No (recommended) | No | Yes |
| A (sterile) | Recommended | No | Yes (with sterility evidence) |
| B | Yes (ISO 13485) | No | No |
| C | Yes (ISO 13485) | Yes | No |
| D | Yes (ISO 13485) | Yes (mandatory) | No |
The Essential Principles cover: (1) Risk analysis and management; (2) Design and development; (3) Manufacturing and production; (4) Clinical evaluation; (5) Labelling and instructions for use; (6) Post-market surveillance; (7) Adverse event reporting; and (8) Product liability and recall procedures.
CAB review of technical documentation typically takes 60–90 days for Class C devices and 90–120 days for Class D devices, depending on dossier completeness and CAB workload. The manufacturer may receive requests for clarification (RFCs) which may extend the timeline by 30–60 days.
If a CAB identifies non-conformity with Essential Principles, the manufacturer must either: (1) modify the device; (2) provide additional technical data or clinical evidence; (3) request a reassessment; or (4) withdraw the application. MDA will not proceed with registration until conformity is demonstrated.