The transitional provisions associated with the MDR have raised a large number of practical questions. A European working group has examined these questions closely and prepared an FAQ document that was published on 18 January 2018.
FAQ on the MDR
FAQ on the IVDR
The transitional provisions associated with the IVDR have raised a large number of practical questions. A European working group has examined these questions closely and prepared an FAQ document that was published on 18 January 2018.
Factsheets for manufacturers of medical devices and IVD published by the European Commission
July 20th, 2018. The European Commission has published factsheets for manufacturers with the most important information on the MDR / IVDR:
MDR & IVDR: 2nd National Conference: Effects on Switzerland, 28 March 2018 – Swissmedic's answers to the questions
29 August 2018: In the following document you will find all the questions that were asked at the 2nd National Conference on MDR and IVDR (held in Bern on 28 March 2018) that have been answered by Swissmedic.
Medical Devices Nomenclature
02.04.2019. The European Commission, in cooperation with the MDCG (Medical Device Coordination Group), has decided to use the Italian CND nomenclature for the future Eudamed (European database on medical devices), in line with Article 26 of the MDR and Article 23 of the IVDR. Mapping to the GMDN (Global Medical Device Nomenclature) will be made available.
Further information about the European Commission’s selection process can be found here:
Information on the CND nomenclature can also be found on the website of the Italian authorities: