Don’t Fall Short  with New EU MDR Deadline

According to the EU Commission, extending the transition period would not compromise patient safety. “The application of the extended transition periods will be subject to several cumulative conditions, in order to ensure that only devices that are safe and for which manufacturers have already taken steps to transition to the Medical Devices Regulation will benefit from the additional time,” the Commission said, pointing to the COVID-19 pandemic, supply chain disruptions, notified body capacity and economic operator preparedness as factors necessitating the delay

The proposal comes one month after members of the European Council expressed support for delaying the EU MDR transition period. In a meeting before the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Brussels on December 9, 2022, European Health Commissioner Stella Kyriakides recommended the delay given the multiple issues putting a “strain on market readiness.”

The EU MDR is complemented by the In Vitro Diagnostic Regulation (IVDR) which became applicable on May 26, 2022, marking the start of a staggered extension of its transition period for manufacturers and economic operators. Both EU MDR and IVDR were created to meet the constantly evolving technological and scientific progress requirements for medical devices. With more than 500,000 types of medical devices on the market, the EU MDR has paved the way to supplying a more patient-focused approach to regulations. The approval of an extended transitional period was a clear effort to help prevent device shortages and help companies meet the need for innovative, high-performing devices and new therapies.