On January 17, 2018 the CAMD (Competent Authorities for Medical Devices) published the answers to the questions arose from the internal work group, created to provide information on the numerous questions on the transition phase of the Medical Device Regulation (MDR) 2017/745 and at the In-Vitro Medical Device Regulation (IVDR) 2017/746.
The document, subject to continuous updating, defines the date of entry into force of the MDR on May 26, 2020 and of the IVDR on May 26, 2022 and the simultaneous expiry of the current Directives application deadline. However, it is possible to place on the market Medical Devices and IVDs complying with the MDR and IVDR.
Moreover, the FAQs remove the doubts related to the certificates currently issued by the Notified Bodies and their validity, granting large time periods to exhaust the stock of Medical Devices already on the market in compliance with the Directive still in force.
EUDAMED platform implementation timeframes are also provided, which include possible extensions for its finalization, as well as transition periods allowing interested parties to enter data into the database.
For more information:
http://www.camd-europe.eu/sites/default/files/media/documents/FAQ_MDR_180117_V1.0.pdf
http://www.camd-europe.eu/sites/default/files/media/documents/FAQ_IVDR_180117_V1.0.pdf
