The implementation of the new MDR leads to a long list of questions that need to be clarified.
The European Group of "Competent Authorities medical devices" (CAMD) started an initiative to give the interested parties further guidance.
The "Transition Sub Group" under the CAMD published the first FAQ concerning open questions on the transition of the MDR.
The FAQ includes typical questions of manufacturers such as:
- Is it possible to place a device, which is compliant with the MDR (= MDR compliant device), on the market prior to 26 May 2020? - (YES)
- Is it possible for a Manufacturer to have valid MDR and valid AIMDD/MDD certificates in parallel until the 27 May 2024 expiry date? - (YES)
Have a look at the Version 1.0 of the CAMD FAQ document.