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.
EU Commission/MDCG Factsheets for manufacturers of medical devices and IVDs
The EU Commission and the Medical Device Coordination Group (MDCG) continually publish various factsheets containing important information on the implementation of the MDR/IVDR as well as guidance documents on specific topics. Below you will find direct links to a selection of documents:
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:
Single Registration Number (SRN)
From 26.05.2020 onwards, the new Regulation (EU) 2017/745 on medical devices will be fully applicable within the European Union. Switzerland is endeavouring to incorporate these requirements into Swiss legislation. This also includes the need for Swiss manufacturers, European authorised representatives and importers to register in the European database on medical devices (Eudamed). Once the registration has been validated by Swissmedic, Eudamed will assign a Single Registration Number (SRN) to the economic operator.
A collection of the most common questions and answers can be found in the following FAQ: