As recently reported (see Sidley Update on the draft Corrigendum No. 2 here), the medtech industry has been eagerly awaiting the second corrigendum to the Medical Devices regulation (MDR). On December 17, 2019, the final version of the second corrigendum to the MDR (Corrigendum No. 2, available here) was approved. The text is expected to be published in the Official Journal of the European Union (OJEC) in early January 2020. Sidley prepared a consolidated version of the amended MDR, which can be accessed here.
Corrigendum No. 2 makes some corrections and — importantly — adds a four-year transition period for certain medical devices that are now classified as Class I but would be moved into a higher-risk class under the MDR. This grants much-needed relief for manufacturers of certain low-risk medical devices. Products that will benefit from the transition period are, in particular, certain software that qualifies as medical devices.
To benefit from the transitional provisions, medical devices must continue to comply with applicable Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD) requirements after May 26, 2020, and there must be no significant changes in the design or intended purpose of the medical devices. Stakeholders should therefore be aware that draft guidelines on what constitutes a “significant change” under the MDR with regard to devices covered by certificates according to the MDD or AIMDD are currently being developed. These new guidelines will be important for any medical devices subject to the transitional provisions in the MDR.
Corrigendum No. 2 does not address applicability of the new transition period to products from third countries, but any of the transition periods under the MDR should apply to medical devices manufactured in third countries.
A second corrigendum to the In Vitro Diagnostic Regulation (IVDR) has also been approved (available here). This corrigendum does not propose the same transition period for certain low-risk IVD devices (most likely because there is still some time before the IVDR applies on May 26, 2022). IVD manufacturers should, therefore, continue their preparations to comply with the IVDR.
Companies placing or intending to place medical devices on the EU market after May 25, 2020, should consider how the MDR, its transitional rules and the various guidelines may affect their operations and whether any changes may be necessary. The new rules are generally expected to represent significant additional work for medical devices manufacturers to ensure a smooth transition and avoid supply interruptions.