Earlier this month, the European Commission published a "rolling plan" for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD's (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.
The rolling plan will be reviewed quarterly to provide operators with the latest information. Currently, the plan notes that as of mid-September 2018, 33 applications have been received from notified bodies to be designated under the Regulations, and that these applications cover the full scope of devices under the MDR and IVDR. A number of action points in relation to the new EUDAMED database are also included. The rolling plan indicates that the Commission is on track for the database to be operational before March 2020. However, considering how many different functionalities the database must include, the timelines seem optimistic.
The Commission and Medical Device Coordination Group (MDCG) have also issued guidance for consultation to assist stakeholders implement the MDR and IVDR. The new guidance deals with the details of the unique device identification (UDI) systems, designed to assist traceability and identification of devices. Although not legally binding, the guidance has been endorsed by the MDCG and is intended to be updated as the authorities, and manufacturers, prepare for the implementation of the Regulations. It is also worth noting that the IMDRF (International Medical Device Regulators Forum) consultation on UDIs closed on 12 October. Once these international documents are finalised, it is expected that they will act as a useful framework for the EU documents, in order to form a basis for international regulatory convergence.