The European Commission recently adopted a new version of the medical device and diagnostics standardization request, adding more standards and extending deadlines by four years. Harmonized standards are published in the European Union’s Official Journal and provide conformity with essential requirements of regulations. European standards organizations, such as CEN and Cenelec, are responsible for developing these standards.
The initial standardization request in April 2021 set the list of standards to be harmonized with the MDR and IVDR. The request included separate lists of standards to be modified and created, requiring submission of joint work programs and progress reports to the Commission. The new draft standardization request adds more standards to be harmonized and modifies timelines due to resource limitations and delays in the harmonization process.
The new request includes standards related to chemical disinfectants, respiratory equipment, medical electrical equipment, and laboratory equipment. It also extends deadlines for the adoption of some standards until December 2028. Some standards are being removed from the original request due to changes in requirements or redundancy.
The request aims to align standards with the MDR and IVDR regulations, providing manufacturers with a comprehensive list of standards for conformity. An analysis of the request shows that while some standards have already been harmonized, many are overdue for adoption. The discrepancy in deadlines and the low completion rate of harmonized standards highlight the ongoing challenges in standardization.
Overall, the new standardization request adds more standards, extends deadlines, and aims to support compliance with the MDR and IVDR regulations. Manufacturers will benefit from a clearer framework for conformity and regulatory requirements. However, challenges remain in meeting the deadlines and ensuring all standards are harmonized effectively.
