European Commission launches portal to ease transition to new two Regulations


European Commission launches portal to ease transition to new two Regulations

In the editorial of the newsletter dedicated to health published by the European Commission on 12 April 2019, Timo Pesonen, the new Director General of the European Commission's Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG Grow), discusses the Medical Devices section on the European Commission's website that was updated to help smooth the transition to two new Regulations on medical devices and in vitro diagnostic medical devices. The portal presents the new regulatory requirements in various sections targeted at impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).

With the presentation of the new portal, Timo Pesonen takes the opportunity to underline the importance of the introduction of the new Regulations (MDR 2107/745 and IVDR 2017/746) arisen from the need to bring the legal framework closer to the progress made over the last 20 years.

According to Timo Pesonen, the new regulations will introduce various benefits, including the improvement of the quality and safety of devices on the EU market by reinforcing the criteria for the designation of Notified Bodies and processes for their oversigh, introducing stricter pre-market control of high-risk devices and strengthening post-marketing surveillance. Furthermore, they will lead to the improvement of the identification and traceability of medical devices, creating a system to uniquely identify medical devices along the supply chain.

The new regulations will also increase transparency, in fact, EUDAMED will make publicly available summaries of safety and clinical performance of high-risk medical devices, as well as containing information on devices, economic operators, clinical research and post-marketing surveillance. In addition, it will help the competent authorities coordinate activities and exchange information and will be used to report and track any incidents.