The European Commission has revamped its medical device section on its website to include a portal that presents the new regulatory requirements targeted at impacted actors.
It has been revamped to help smooth the transition to two new regulations on medical devices and in vitro diagnostic medical devices, which affects manufacturers, importers, health institutions, authorities in non-EU countries and others. It explains the main differences between the current Directives and the new regulations, and highlights the timeline for the new transition along with deadlines for implementation.
It has been revamped to help smooth the transition to two new regulations on medical devices and in vitro diagnostic medical devices, which affects manufacturers, importers, health institutions, authorities in non-EU countries and others. It explains the main differences between the current Directives and the new regulations, and highlights the timeline for the new transition along with deadlines for implementation.
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 three-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 five-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.
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.”
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.”
