The EC renovated the Medical Devices section on its website to facilitate the transition of the two new Regulations on medical devices and in vitro diagnostic medical devices, the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) respectively.
The portal explains the principal differences between the current Directives and the new Regulations and therefore presents the new regulatory requirements concerning the impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).
Moreover, the renovated portal provides resources for journalists interested in the medical industry, such as factsheets explaining the impact of the Regulations on stakeholders across the sector, FAQ clarifying the technical aspects of the Regulations and a contacts page which can be used to request additional information.
Background
The new MDR was published in May 2017 and, after a 3-year transition period, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). The IVDR was also published in May 2017 and, after a 5-year transition period, will replace the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD).
Contrarily to Directives, Regulations are directly binding and do not leave space to Member States to transpose them into their national law, minimising the risk of discrepancies and misinterpretations.
The new Regulations are expected to improve the quality and safety of devices across the EU by implementing a new system of unique device identifiers (UDIs). Furthermore, transparency should be enhanced, as information on high-risk medical devices, as well as on their safety, clinical performance and post-market surveillance, will be publicly available through the European database on medical devices (EUDAMED).
