By Robert Kerwin
Five years ago, with the adoption by the European Union of Regulations (EU) 2017/745 — the “EU MDR”, the European regulatory framework changed significantly.
The EU MDR applies to all medical device manufacturers who intend to place products in the European Union. Much has been accomplished with the development of the joint assessment process for designating notified bodies (accrediting organizations), publication of harmonized standards, as well as the publication of a large number of guidance documents from the member states through their participation in the European Commission’s Medical Device Coordination Group (“MDCG”). MDCG has made clear that manufacturers are responsible to ensure that their devices comply with the MDR as of May 2024... What’s the concern?
As an MDCG position paper
published in June acknowledges, data from the notified bodies has shown that more than 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024.
The EU Health Commissioner Stella Kyriakides reportedly told the EU Health Ministers in June that 24,000 previously issued device certificates will expire by May 2024. In her opening remarks at the EPSCO Council-Medical Devices last month, she warned: “[we] cannot risk facing shortages, and it is therefore extremely important that manufacturers get ready for the new requirements before the transition period ends.”
While transitional provisions have been in place under the MDR to give further time for manufacturers to get ready their quality management systems and to prepare technical documentation before applying to a notified body, the MDCG has reported that data collected from the notified bodies as of December of last year, showed nearly 37% of the manufacturer applications were refused on the basis of being incomplete. The MDCG noted as of April 2022, that the notified bodies have indicated that more than 50% are incomplete.
Those manufacturers who may have delayed applying to the notified bodies for conformity assessment may well be held accountable for implementation problems with the EU MDR. The MDCG has noted that from that May 2024 date, medical devices not certified under the MDR will have no access to the EU market.
In a position paper
published last year on the MDR/IVDR implementation, Team NB forewarned that notified bodies’ capacity and resources were already facing a challenging situation as, in addition to the issues relating to the pandemic, they were performing the Directives surveillance activities while managing new MDR/IVDR applications.