Glossary Term
Declaration of Conformity
Definition
A Declaration of Conformity (DoC) is a formal document issued by a manufacturer stating that their medical device complies with applicable regulatory requirements, standards, and directives. In the MedTech industry, it is an essential part of demonstrating compliance with frameworks such as the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
Relevance to the MedTech Industry
The DoC serves as a manufacturer’s attestation of product safety, performance, and regulatory compliance, ensuring that the device can be legally marketed and used in the specified region. It is a cornerstone of regulatory submissions and market access.
Additional Information & Related Terms
CE Marking A certification that often relies on the Declaration of Conformity for regulatory compliance in the EU.
ISO 13485 A quality management system standard referenced in the DoC to ensure manufacturing compliance.
Risk Management File A key document that supports the DoC by detailing risk assessments and mitigations.
Post-Market Surveillance Ensures ongoing compliance to maintain the validity of the DoC.