Conformity Assessment

What is conformity assessment?

The ISO overview of conformity assessment defines it as demonstrating that specified requirements have been fulfilled. Those requirements may come from regulations, standards, contracts or other normative documents.

For medical devices, conformity assessment can cover the product, its technical documentation, manufacturing processes and the manufacturer’s quality management system.

What activities can be part of conformity assessment?

Depending on the applicable framework, conformity assessment may include testing, inspection, document review, quality-system auditing, validation, verification or certification.

No single activity proves every aspect of conformity. A laboratory test may address electrical safety, for example, while clinical evidence supports performance and an audit evaluates the quality system. Manufacturers must assemble the evidence required for the complete regulatory pathway.

When can a manufacturer use self-assessment?

Some lower-risk devices allow the manufacturer to assess conformity and issue its own declaration without routine third-party review. Higher-risk products commonly require an independent conformity assessment body.

The rules are jurisdiction-specific. Under the EU Medical Device Regulation, the device class and characteristics determine which procedures in the MDR apply and whether a notified body must participate.

Is conformity assessment the same as certification?

No. Certification is a form of third-party conformity assessment in which an independent body provides written assurance that specified requirements are met. Conformity assessment is the broader concept and may include first-party, second-party or third-party activities.

A certificate also has a defined scope. It should not be treated as evidence for products, sites, standards or activities outside that scope.

How does conformity assessment relate to CE marking?

For devices subject to EU MDR or IVDR, the manufacturer completes the applicable conformity assessment, prepares technical documentation and an EU declaration of conformity, and then affixes the CE marking. Where required, a notified body participates and its identification number accompanies the mark.

CE marking is not an EU government endorsement. The manufacturer remains responsible for compliance. Pure Global provides related support for EU MDR, EU IVDR and notified body selection.