EU Regulatory Framework for Medical Devices: State of Play on the Implementation of the New Regulations
9:10 AM - 10:00 AM
The EU regulatory framework for medical devices evolved in 2017 with the adoption of two new Regulations for medical devices (fully applicable in May 2021) and for in vitro diagnostic medical devices (fully applicable in May 2022) to keep up with advances in science and technology, and to ensure the highest degree of health and safety of patients, users and citizens in general. The implementation of these new regulations is a very challenging task involving all the sectorial actors: European Commission, national competent authorities and healthcare systems, economic operators (manufacturers, authorised representatives, importers, distributors…), conformity assessment bodies (“notified bodies”), etc.
This presentation will show the state of play of the implementation in its different aspects, in particular with respect to conformity assessment, standardisation, expert panels, reprocessing, UDI, European database (“Eudamed”), information and participation, governance structure, etc., as well as the perspectives towards the dates of fully applicability of the new regulations and beyond, through the relevant transitional provisions from the old directives. It will also provide key references for information and guidance publicly available to all the interested parties and in continuous development by the Commission and the sectorial working parties to support the implementation of the new regulations.