|The European Union Medical Device Regulation (EU MDR) issued in May 2017 had contemplated a three-year transition period that would have ended May 26, 2020. After this time, a four-year “soft” transition period would have allowed organizations to continue using their existing MDD certificates through May 26, 2024.|
|As part of this amendment, Article 59 has been modified to postpone the application of the MDR and to free up resources to address COVID-19 issues by allowing individual Member States to authorize medical devices without a CE mark in their respective territories if there is a public health or a patient safety interest. The Commission may extend individual Member States’ decisions to authorize the use of non-CE marked devices across the rest of the EU.
To ensure common understanding of the new regulations, several task forces have been tasked with developing guidance documents, overseen by the NBs.
Hundreds of experts have been identified and are under review by MDCG. It is expected that they will be appointed in late July 2020, after which panels will begin to be structured.
To date, 11 Expert Panels have been identified by EU 2019/1396 – regarding implants:
While the Commission hasn’t clarified when economic operators should expect the the European Databank on Medical Devices (EUDAMED) to be functional, there was an indication in December 2019 that it will go live at the same time IVDR takes effect: May 26, 2022.
While medical device manufacturers have an extra year to comply with MDR, there are no changes in end dates; therefore, a grace period mechanism after May 2024 has not been contemplated.
|Trevino M (TregMedical)||Med Device Online 08 Jul 2020|
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