Conformity
Conformity (compliance) generally describes the fulfilment of specified requirements. In EU product law it describes a product's alignment with the essential safety and performance requirements of the applicable EU regulation.
Conformity in the context of medical devices (MDR):
- A medical device is conformant when it meets all essential safety and performance requirements in MDR Annex I
- The manufacturer declares conformity through the EU Declaration of Conformity
- A presumption of conformity exists when harmonised standards have been applied
Conformity in the context of PPE:
- A PPE product is conformant when it meets the essential health protection and safety requirements of PPE Regulation (EU) 2016/425 Annex II
Distinctions:
- Conformity is a legal term (fulfilment of regulatory requirements)
- Quality is a technical term (degree of requirement fulfilment overall)
- Conformity is a necessary condition for placing on the market but does not guarantee high quality beyond the regulatory minimum
Conformity assessment is the process that demonstrates conformity.
Frequently asked questions
What is the difference between conformity and quality?
Conformity means meeting minimum legal requirements. Quality describes the overall degree of requirement fulfilment - a product can be conformant but of lower quality if it only barely meets minimum requirements.
What is a presumption of conformity?
A presumption of conformity exists when a product complies with harmonised standards referenced in the EU Official Journal. In that case it is presumed to meet the essential requirements of the associated EU regulation. The presumption is rebuttable.
Can a manufacturer self-declare conformity?
Yes - for Class I medical devices (without Is/Im/Ir) and PPE Category I, the manufacturer may independently assess and declare conformity. From Class IIa and PPE Category II upwards, a Notified Body must be involved.