Declaration of Conformity – Then and Now

In the MDD, the concept of using harmonized standards is discussed, particularly in relation to demonstrating conformity with the essential requirements of the Directive. However, the Directive does not explicitly mandate the inclusion of a list of standards in the Declaration of Conformity. Annex II (Full Quality Assurance System) and Annex VII (EC Declaration of Conformity) discuss conformity assessments and the use of harmonized standards, but they do not require the standards to be listed in the DoC.

In the MDR the use of harmonized standards is also a key method for demonstrating compliance with the General Safety and Performance Requirements (GSPR). While the MDR encourages the use of harmonized standards to achieve presumption of conformity, it similarly does not explicitly require these standards to be listed within the Declaration of Conformity. Article 19 and Annex IV outline what should be included in the DoC. Annex IV does not specify that harmonized standards or any standards need to be listed, but it emphasizes the importance of demonstrating conformity with the GSPR.

In practice, although not mandated, manufacturers often include references to relevant (harmonized) standards in the DoC or other technical documentation to demonstrate how conformity with the essential requirements (MDD) or the GSPR (MDR) was achieved. This practice is common because it provides clarity and transparency in how compliance was achieved, especially during audits or inspections by Notified Bodies or regulators. While not required by law, including these standards in the DoC or associated documentation is considered good practice for clear communication and demonstration of compliance.

The advantages of including the standards are obvious. Including the standards helps demonstrate that the product complies with recognized benchmarks, which can streamline regulatory reviews and audits. It provides clarity and transparency to regulators, Notified Bodies, and customers about how the manufacturer achieved compliance with the essential requirements or GSPRs. And last, during audits or inspections, having the standards listed can make it easier for auditors to verify compliance, potentially reducing the time and effort required to pass an audit.

There are also disadvantages. Standards can be updated or replaced over time. If the standards listed in the DoC become outdated, the DoC itself may be considered out of date, which could necessitate frequent updates to maintain regulatory compliance. Updating the DoC to reflect changes in the standards can be an administrative burden, particularly if changes occur frequently. This can add complexity to maintaining compliance documentation. By explicitly listing the standards, a manufacturer may inadvertently create regulatory risks if there is a dispute over whether the product truly meets all aspects of the listed standards. This could occur if there’s a difference in interpretation, or if the product fails to fully comply with a newer version of the standard.

While no requirement for the listing of (harmonized) standards can be found in MDD or MDR, the guidance documents are contradicting. The guidance from the EK MED 3.9 A.4  lists standards as additional information but says: “Optional; If standards are mentioned, all applicable parts of the standards must be fulfilled.”, indicating that it is not mandatory to list (harmonized) standards. On the Your Europe website (a European Commission website which provides information to citizens and businesses on their rights in the EU) harmonized standards are listed of the required content for an DoC. The website is applicable to every kind of product that is regulated in the European Union and not limited to medical devices. In other regulations such as the EMC directive, a separate requirement (Annex IV point 6) for not only the listing of harmonized standards but also the need for the date of the standard is available.

Conclusion

The DoC is a cornerstone of regulatory compliance in the medical device industry. As the industry transitions from the MDD to the MDR, the requirements for this document have become more detailed and rigorous. Manufacturers must carefully navigate these changes, ensuring that their DoCs are comprehensive, accurate, and fully compliant with the latest regulations. By understanding the key differences between MDD and MDR, and by addressing the challenges involved in setting up a correct DoC, companies can ensure that their devices are not only compliant but also safe and effective for patients. Due to the unclear situation, I would recommend always checking with the notified body whether they expect the list of (harmonized) standards at the DoC.

By Verena Wieser, Medical Device Consultant