Plan published for new Medical Devices Regulation and In Vitro Diagnostics Regulation implementation
Earlier this year the European Commission released a new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to be implemented from 26 May 2020 and 26 May 2022 respectively. Through over 50 implementation and delegation acts the regulations will have significant impacts on the process of manufacturing, distributing and assessing medical devices and regulating their entry onto the market.
The European Commission has now published a rolling plan which shows a list of the actions to be introduced and predicted timelines for this. The actions stated include those regarding single-use medical devices, products without a medical purpose, expert panels, expert and EU reference laboratories, designation of issuing entities for the UDI system, EUDAMED and specifications for Class D in vitro diagnostic medical devices. The rolling plan will be reviewed by the European Commission and updated quarterly.
The Commission and Medical Device Coordination Group (MDCG) have now also issued guidance, to help stakeholders implement the regulations, which will be kept updated. This includes information on requirements for unique device identification (UDI) systems such as:
- MDCG 2018-3 Guidance on UDI for systems and procedure packs
- MDCG 2018-4 Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs
- MDCG 2018-5 UDI Assignment to Medical Device Software
- MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16
- MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database