By Robert J. Kerwin
During a meeting in Brussels of the EU Health Ministers last week, the ministers signaled support for the passage of proposed legislation to amend the EU MDR to provide additional time for manufacturers to obtain the necessary medical device conformity assessment certifications to comply with its provisions. Depending upon the risk classification, approval of the legislation would give manufacturers until May 2027 to comply.
Though the EU Medical Device Coordination Group (“MDCG”) had worked extensively on a number of non-legislative actions to enhance notified body capacity, the May 2024 deadline for obtaining most device certifications under the EU MDR remained of great concern to the Health Ministers. The notified bodies, the independent assessment organizations approved to assess the conformity of devices being placed on the EU market, had
publicly discussed that the transition process was slow in light of the deadline approaching.
Many certifications issued previously under the Medical Device Directive would otherwise have been void and the devices to which they pertained potentially not available on the EU market after May 27, 2024. The notified bodies capacities were variously reported as limited as, among other things, some assessment organizations have not as yet been approved for issuance of EU MDR certifications.
Certification requires, among many other things, the undertaking of on-site audits of a manufacturer’s quality management systems and if applicable, the manufacturer’s subcontractors. Even with the legislative extension, which is expected to pass, industry observers have noted in essence that this is no time to delay compliance. In 2027, the European Commission will undertake a comprehensive evaluation of the MDR, but compliance in the interim is very much a first priority.
Best practices for MDR compliance were the subject of a very illuminating presentation during the Fall IAMERS European meeting in Strasbourg. The advice offered by Martina Pieper, senior marketing manager at Dunlee, remains solid:
Conduct gap assessments of your QMS + Technical Documentation with regard to the MDR, close the identified gaps and prioritize these projects on the management level with a further governance program to gain visibility. Also key: ask your notified body for capacities 3-6 months before sending your documents.
While the MDR deadlines may shortly be pushed, the need for immediate actions for compliance is now.
About the author: Robert J. Kerwin serves on behalf of IAMERS as an approved industry observer to the EU Medical Device Coordination Group. The comments and observations contained in this article are his own.
