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 recognised 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 of a representative device specimen
- Assessment of technical documentation against Essential Principles
- Used for some Class C and D applications
- QMS certificate also required
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 major international notified bodies and testing organisations operating in the Asia-Pacific region.
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 |