On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively.
These documents include:
- Factsheet for authorities in non-EU/EEA stated on Medical Devices and in vitro Diagnostic Medical Devices;
- Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and in vitro Diagnostic Medical Devices;
- Factsheet for Manufacturer of Medical Devices;
- Medical Devices Regulation (MDR) and In vitro Diagnostic Medical Devices (IVDR)- infographics;
- Implementation Model for in vitro Diagnostic Medical Devices Regulation- Step by Step Guide;
- Implementation Model for the Medical Devices Regulation- Step-by-Step;
- Factsheet for the Procurement Ecosystem of Medical Devices and in vitro Diagnostic Medical Devices;
- Transition timelines from the Directive to the Regulations- Medical Devices and in vitro Diagnostic Medical Devices.
These documents include high-level information concerning the main changes introduced by the MDR and IVDR, guidance concerning the transitional provisions or the Regulations and “frequently asked questions”. The step-by-step implementation model documents could be useful for manufacturers to plan transition to the new Regulations or to determine which steps they still need to take.