The European Commission announces its new portal which aims to aid the transition to new regulations regarding medical devices.
New Portal
The recently launched medical devices section on the European Commission's website has been revamped to help smooth the transition to the 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 such as manufacturers, importers, health institutions, and authorities in non-EU countries.
The new EU Medical Devices Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 bring EU legislation in line with technical advances, changes in medical science, and progress in law making.
The revamped website explains the main differences between the current directives and the new regulations and highlights the timeline for the transition along with deadlines for implementation. The new portal also offers resources targeted at journalists interested in the medical industry, including factsheets explaining the impact of the regulations on stakeholders across the sector, FAQ that shine light on technical aspects of the regulations and a contacts page through which journalists can request additional information.
At the launch of the portal, Elżbieta Bieńkowska, commissioner for internal market, industry, entrepreneurship and small and medium-sized enterprises, said: “With the new regulations, Europe introduces robust rules that improve clinical safety and create fair market access. The new website will help ease transition to the new regulations for all stakeholders in the medical devices and in vitro medical devices ecosystem.”
The MDR will replace the existing Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. The MDR was published in May 2017, marking the start of a 3-year period of transition from the MDD and the AIMDD.
The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. The IVDR was published in May 2017, marking the start of a 5-year period of transition from the IVDD.
In contrast to directives, regulations are directly applicable and do not need to be transposed into national law. This means the regulations should lower the risk of discrepancies in interpretation across the EU.
The new regulations will aim to improve the quality and safety of devices on the EU market. In particular, they will reinforce the criteria for the designation of notified bodies and processes for their oversight, introduce stricter pre-market control of high-risk devices and strengthen post-market surveillance.
One of the main new features of the regulations is a completely new system of unique device identifiers (UDIs), which hope to improve the identification and traceability of medical devices. It will try to create a system to uniquely identify medical devices along the supply chain.
The new regulations will also aim to increase transparency. Summaries of safety and clinical performance for high risk medical devices will be publicly available via the European database on medical devices (EUDAMED). The database will include information on devices, economic operators, clinical research and post-market surveillance. EUDAMED will help regulatory authorities coordinate and exchange information and will be used to report and track incidents.