Description

The Declaration of Conformity is a key document required under the European Union Medical Device Regulation (EU MDR). It is issued by the manufacturer or authorized representative and attests that the medical device complies with all relevant regulatory requirements outlined in the MDR. This declaration signifies that the device meets essential safety and performance criteria, has undergone the necessary conformity assessment procedures, and is authorized for placement on the EU market. The Declaration of Conformity serves as a formal statement of the manufacturer’s responsibility for the device’s compliance and is essential for obtaining CE marking. It provides transparency and assurance to regulatory authorities, healthcare professionals, and patients regarding the device’s regulatory status and adherence to safety standards.