Glossary Term
Manufacturer's Declaration of Conformity
Definition
The Manufacturer's Declaration of Conformity (DoC) is a formal document in which the manufacturer declares that their medical device complies with all applicable regulatory requirements, standards, and directives. It serves as a key part of the regulatory approval process in regions such as the European Union and is typically required before the device can be marketed or sold.
Relevance to the MedTech Industry
The DoC demonstrates a manufacturer’s commitment to compliance, quality, and safety. It ensures that medical devices meet required performance standards, are safe for intended use, and comply with regional regulations such as the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
Additional Information & Related Terms
Challenges or Considerations
Regulatory Complexity Preparing a DoC requires a deep understanding of applicable directives, standards, and regional requirements, such as EU MDR, FDA regulations, or global harmonization efforts.
Comprehensive Documentation The DoC must reference a wide range of supporting documents, including risk assessments, clinical evaluations, and quality certifications.
Continuous Compliance The DoC must be updated whenever significant changes are made to the device, standards, or applicable regulations.
Liability By signing the DoC, manufacturers assume legal responsibility for the compliance and safety of their device.
Examples of Applicable Standards and Regulations
EU MDR (2017/745): Regulation governing medical devices in the European Union.
ISO 13485: Quality management systems for medical devices.
ISO 14971: Risk management for medical devices.
IEC 60601-1: Safety and performance standards for electrical medical devices.
FDA 21 CFR Part 820: Quality system regulation for medical devices in the United States.