The Competent Authorities for Medical Devices (CAMD) Executive Group’s medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining the priority actions for the various technical work streams.
In the roadmap the key activities and their priority levels for seven (7) technical areas/work streams for implementation and one category including over-arching/cross-cutting issues categories are listed. The workstreams are:
- Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD)
- Scope & Classification
- Notified Bodies & Conformity Assessment
- Post-Market Surveillance & Vigilance for both MD and IVD
- Eudamed & UDI
- Market Surveillance
- IVD-specific Issues
- Over-arching & Cross-cutting Priorities
The objective is that each working group develop a project plan specifying the timeframes and key milestones to deliver on the implementation plan. Many of the deliverables are guidance documents.
The majority of priorities related to IVDs have been captured within the technical areas, however the IVD-specific workstream allows issues specific to IVDs to be addressed. High priority activities related to IVDs listed in the road map include:
- Performance Evaluation and Performance Studies
- Template document development
- Classification guidance for IVDs around classification rules and scope, giving practical examples.
- Guidance on the notified body designation process for joint assessments under the new regulations.
- Guidance on requirements for vigilance reporting.
- Guidance for UDI assignments.
- Reference Laboratories.
QARAD will continue to monitor the progress made by the various workstreams and will keep you updated of relevant changes.