Two leading medical industry groups in the European Union (EU) are calling on the European Commission to extend the transition period for the EU’s Medical Device Regulation (2017/745) to avoid what they call a potential “collapse in patient care.”
According to a recent posting on the website MedTech Dive, the medtech industry associations Snitem (France) and BVMed (Germany) are calling for a two-year extension of the MDR for Class III and implantable products, and a four-year extension for all other products to “ensure the availability of medical products with the resources available.” The MDR transition period for all products is currently scheduled to end in May 2024.
A number of companies and trade groups have reportedly raised concerns about the limited capacity of the existing pool of 27 notified bodies to handle the testing and certification already required for those medical devices that currently fall under the scope of the MDR. Snitem and BVMed estimate that only 1000 of the approximately 25,000 certificates that need to be transferred to the MDR prior to the transition deadline have been issued to date, with the average duration of the certification process stretching out an average of 18 months.
The concerns being voiced by Snitem and BVMed, whose members together account for more than 50% of the medical device market in the EU, echo those raised by MedTech Europe in May 2021, which noted that the implementation of the MDR continues to present roadblocks that will “limit the sectors ability to seamlessly supply certified devices under the new rules.” According to the MedTech Europe, these roadblocks mean that “European patients are losing their previous opportunities to be the first to benefit from critical medical technology innovation.”