Brussels, 23 January 2018. The Medical Device Regulation (MDR)* is one of the top priorities for COCIR. The Regulation’s implementation process is now in a critical phase, with secondary legislation being drafted. COCIR and its members are actively involved in the process, through continuous engagement in dedicated expert groups (e.g. EUDAMED, Clinical Evaluation, Vigilance) in support of the European Commission and Member States, through CAMD and the newly created MDCG. Our latest contribution released today highlights the impact of the MDR on our medical device industry, addressing the general framework, pre- and post-market obligations for manufacturers as well as the relevant actors in the implementation process. We are laying out the focus areas to ensure a timely and successful implementation, so innovation is not affected by this important new Regulation.
In this context, COCIR welcomes the recent publication of the CAMD MDR Transition Provisions FAQ on 17 January 2018 (find the document here), which clarifies several questions on the implementation provisions of the MDR in Article 120. COCIR is looking forward to updated versions of this important guidance document.
As UDI is a critical topic for industry, we are happy to co-partner with the European Commission and Medtech Europe to organise an International Workshop on the Global Use of Unique Device Identification (UDI). It takes place on 12 February 2018 in Brussels. Register here!
*The Medical Device Regulation was adopted in May 2017 and its Date of Application is 26 May 2020.