On March 7, 2023, the European Council (“EC”) unanimously approved an extension to the transition deadlines for the certification of medical devices under Medical Device Regulation MDR 2017/245 (“EU MDR”). The EC also approved the elimination of the sell-off dates (the end date after which devices currently being sold would need to be withdrawn) under EU MDR and the In Vitro Diagnostics Medical Devices Regulation (“IVDR”), which would have likely resulted in many safe medical devices being pulled from the market.
The EU MDR was published back in 2017 in an effort to improve controls around performance and safety of medical devices through a number of measures including enhanced oversight, more clinical evidence and documentation, more stringent post-market surveillance, and strengthened Clinical Evaluation Reports (“CERs”), as well as many other impactful changes. It had been widely viewed throughout the industry that an extension was needed to alleviate concerns that thousands of critical medical devices could be unavailable to patients due to noncompliance with the previous deadlines. Notified Bodies have struggled to keep up with rising demand for their conformity assessment services which has resulted in a growing backlog. This additional time will allow for Notified Bodies to ramp up capacity and for more Notified Bodies to receive EU MDR designation which will hopefully allow for the backlog to be worked down expeditiously.
Under the previous guidance, the transition deadline for recertification of devices under EU MDR was May 2024. The new transition deadlines are staggered based on risk classification as follows:
- Class III-custom-made implantable devices ~ May 2026
- Class III and IIB implantable devices ~ December 2027
- Class IIB non-implantable devices, Class IIA, and Class I ~ December 2028
Despite these changes to the transition deadlines, experts are strongly advising companies not to delay their preparedness activities. Achieving compliance can be an exhaustive, time-consuming effort requiring a detailed implementation plan, cross-functional input and coordination, and formal governance and oversight. It’s important to note that the extension of the transition period is permitted only under certain conditions. For example, under this updated guidance, manufacturers are still required to have implemented a quality management system and be “EU-MDR Ready” with a filed application with a Notified Body by May 26, 2024.
It is expected that the European authorities will be releasing a Q&A document in March 2023 to address questions regarding the transition deadlines. We will continue to keep you updated!
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