The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. With the introduction of the Medical Devices Regulations (the MDR and IVDR), two groups were set up within the CAMD: (i) the Transition Subgroup, which will develop guidelines on the application of the MDR/IVDR during the transitional period, and details of which aspects of the Regulations devices will have to meet to be placed on the market during this time, and (ii) the Implementation Taskforce to facilitate collaboration and cooperation during the implementation phase of the new Regulations.
Earlier this month, the Implementation Taskforce published a high-level MDR/IVDR Roadmap. The Roadmap is the first glimpse into the intentions of the Commission and authorities across the EU as to how the Regulations will be implemented, and the order in which key guidance and clarification will be developed.
For a number of months, the CAMD has been meeting with stakeholders and the European Commission to identify key issues that require clarification under the Regulations, to identify the need for guidance under the Regulations, and to ensure collaboration and avoid duplication by authorities, notified bodies and stakeholders. The resulting Roadmap sets out a priority list of the issues that need to be addressed, and recommendations on who should take responsibility for addressing them to ensure the Regulations operate as planned. It notes that a harmonised approach to interpretation is fundamental to ensure consistency in the application of the Regulations.
The list of priorities is divided into 8 clusters: seven technical work streams for implementation, and a cluster to address over-arching/cross cutting issues, as follows:
- Clinical evaluation and clinical investigation (for medical devices); performance evaluation and performance studies (for in vitro diagnostic devices)
- Scope and classification
- Notified bodies and conformity assessment
- Post-market surveillance and vigilance
- Eudamed database and unique device identifiers (UDI)
- Market surveillance
- In vitro diagnostic-specific issues
- Over-arching and cross-cutting priorities
While the Roadmap allocates a general priority ranking of high, medium or low to each work item, it is proposed that a detailed project plan is developed by each working group specifying the timeframes and key milestones to deliver the implementation plan.
Many of the deliverables require the development of guidance documents. The MDR and IVDR set out a number of implementing and delegated acts that will need to be introduced to clarify how certain provisions of the Regulations will be applied. However, it is envisaged that additional guidance and information will be needed. In particular, a number of the work items require gap analyses to be undertaken between the current MEDDEV and the requirements in the Regulations. Whether any amendments or additions will take the form of an update to the current MEDDEV guidance, interim guidance until the MEDDEV can be updated, or standalone new guidance, is currently unclear.
The Taskforce itself intends to engage with all parties to develop the project plan and deliverables for each item, and then to continue monitoring the progress of implementation work.