Implementation tools to help transitioning from Directives to Regulations
Posted on 04.07.2019
After the last meeting of the Medical Device Coordination Group, two newly approved guidance documents were published aiming at ensuring a harmonised implementation of Medical Device Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR):
• MDCG 2019-7: Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a "person responsible for regulatory compliance" (PRRC)
• MDCG 2019-8: Implant Card guidance document relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
As part of the European Commission’s communication campaign on the new IVD and MD Regulations, a new factsheet aimed at healthcare professionals and health institutions was published on 17 June. In the DG GROW’s IVDR/MDR information kit, factsheets are already available for IVD and medical device manufacturers, for authorised representatives / importers / distributors and for competent authorities in non-EU/EEA countries, as well as banners and infographics e.g. on the transition timelines.