MDR and IVDR, What’s Up?
The European Commission released a rolling plan for the Medical Device Regulation (MDR) and In-vitro device regulation (IVDR)
October 24, 2018
The rolling plan, that it will become mandatory from 26 May 2020 and 26 May 2022, contains a list of “essential implementing acts and actions” which must be put in place by the European Commission during the transitional period together with relevant information on expected timelines and state-of-play.
The first part of the plan is dedicated to Implementing Acts concerning the reprocessing of single-use medical devices, common specifications for products without a medical purpose, expert panels, expert laboratories, EU reference laboratories, designation of issuing entities for the UDI system, EUDAMED and the common specifications for Class D in vitro diagnostic medical devices. The second part of the plan relates to other actions/initiatives which will also be important for the application of the MDR and IVDR (e.g. notified body designation, implementation plan and functional specifications of EUDAMED).
The document will be revised by the European Commission on a quarterly basis to provide updated information to the competent authorities and stakeholders.
New guidance concerning the UDI system
New guidance documents endorsed by the Medical Device Coordination Group (MDCG) have also been published on the European Commission website:
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”