ARTICLE SUMMARY:
Following a serious setback last year in efforts to formally link consensus technical device standards with compliance to the oncoming EU Medical Device and IVD Regulations, European policymakers are optimistic they can achieve a course correction by this spring, before MDR fully applies in May. Excerpted from Pathways’ Picks, February 24.
Last June, the EU standardization organizations (CEN and CENELEC) rejected the EU Commission’s request to align existing international standards with the MDR/IVDR, making it so firms can’t leverage a “presumption of conformity” to the elements of the new regulations based on compliance to certain standards. The Commission has drafted a revised request that is under internal review and is expected to be sent to CEN/CENELEC by the end of March and, hopefully, accepted sometime in April, according to Mario Gabrielli Cossellu, a medtech policy office at the Commission, who posted an update on standards activities to LinkedIn on February 20. Once that happens, the Commission will be able to start publishing references to harmonized standards in the Official Journal of the EU, which confers the presumption of conformity, Cossellu explained. “By using the technical solutions provided by those standards, sectorial manufacturers may lawfully place their devices on the EU-EEA market in a less burdensome manner,” he writes.
In parallel, the EU Medical Device Coordination Group (MDCG) has drafted a guidance intended to help industry properly leverage standards and clarify concepts including “state of the art.” Cossellu expects the final guidance to be published by April. Finally, the Commission plans to publish addition standards in the OJEU referenced to the current EU Directives (MDD, AIMDD, and IVDD) that will support companies’ efforts to take advantage of the transitional period established by the regulations through May 2024. Progress on the standards developments will be addressed at MCDG’s next full-group meeting, including a closed-door stakeholder discussion, on March 4-5.
Excerpted from “Pathways’ Picks: EU Standards, Mutation Monitoring, CDRH Staff Moves, and More,” Market Pathways, February 24, 2021.
Trial MyStrategist.com and unlock 7-days of exclusive subscriber-only access to the medical device industry's most trusted strategic publications: MedTech Strategist & Market Pathways. For more information on our demographics and current readership click here.