Competent Authorities for Medical Devices publish FAQ on transitional provisions for the IVD Regulation and MD Regulation
Posted on 07.02.2018
The group of Competent Authorities for Medical Devices have published two sets of frequently asked questions on how to interpret many of the transitional provisions under the IVD Regulation and MD Regulation. While the FAQ documents do not cover all questions about how to interpret the transitional provisions, they do cover many essential points, including whether or not devices which do not require a notified body can be placed on the market before MDR Eudamed is available, if it is possible for a manufacturer to have a valid IVDR and valid IVDD certificates in parallel until the 27 May 2024 expiry date, etc.
Both sets of FAQ documents may be found here: http://www.camd-europe.eu/media-centre