MDR, IVDR: Competent Authorities Lay Out Road Map
Posted 13 November 2017 | By
The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams.
The road map divides the implementation work into eight categories, with activities, recommended responsible parties and owners, and priority levels for each:
1. Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD)
2. Scope & Classification
3. Notified Bodies & Conformity Assessment
4. Post-Market Surveillance & Vigilance for both MD and IVD
5. Eudamed & UDI
6. Market Surveillance
7. IVD-specific Issues
8. Over-arching & Cross-cutting Priorities
The objectives outlined were put together based on workshops held at CAMD meetings in Amsterdam and Bratislava in 2016.
"It is important to note that although the MDR and IVDR has specified implementing acts to define how certain provisions are to be applied, it is envisaged that additional guidance and information might be needed in advance. What form this guidance will take and how it will be issued will be dependent on future discussions on specific topics e.g. will an update of current MEDDEV be possible in time," the road map says.
High priority activities highlighted by the road map include: Classification guidance for IVDs with examples, guidance on the notified body designation process for joint assessments under the new regulations, guidance on requirements for vigilance reporting and guidelines for unique device identifier assignments.
The road map’s release comes as EU notified bodies are already prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the regulations continues.
CAMD Implementation Taskforce Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap