The new Medical Devices Regulation (EU) 2017/745 [MDR] and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 [IVDR] bring EU legislation into 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. It highlights the timeline for the transition along with deadlines for implementation (see infographics under 'more information' section below).
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
- 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 SMEs, 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 (93/42/EEC) [MDD] and the Active Implantable Medical Devices Directive (90/385/EEC) [AIMDD]. 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 (98/79/EC) [IVDD]. 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 lower the risks of discrepancies in interpretation across the EU.
The new Regulations will 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
- strengthen post-market surveillance.
One of the main new features of the Regulations is a completely new system of unique device identifiers (UDIs), improving the identification and traceability of medical devices. It creates a system to uniquely identify medical devices along the supply chain.
The new Regulations will also 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.
- Datum objave
- 8 februar 2019
- Generalni direktorat za notranji trg, industrijo, podjetništvo ter mala in srednja podjetja