By order of November 25, 2019, the Committee of the European Parliament proposed the adoption of a few changes to the MDR (EU) 2017/745, including an extension until May 26, 2024 for the full implementation of the MDR for Medical Devices currently classified as Class I that will require the involvement of a Notified Body due to up classification (e.g. Ir, IIa, etc.).
On a similar note, Medical Devices already in possession of a certificate grated under MDD expiring after May 26, 2020 were granted a “Period of Grace” under the MDR, i.e. the possibility of being marketed, in accordance with given conditions, at the end of the certificate.
At the moment, the changes to Class I devices have not yet been definitively approved. It will be necessary to wait for the plenary meeting, that is to be held around December, 20th, for the final outcome of the corrigendum proposal.
