CAMD publishes IVDR and MDR Implementation Roadmap

Posted on 01.12.2017

The group of Competent Authorities for Medical Devices (CAMD) in collaboration with the European Commission has published an Implementation Roadmap for the IVD Regulation and MD Regulation.

The Roadmap provides 8 priority areas for facilitating an effective implementation of the IVDR and MDR:

1. Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD)

2. Scope & Classification          

3. Notified Bodies & Conformity Assessment  

4. Post-Market Surveillance & Vigilance            

5. Eudamed & UDI      

6. Market Surveillance             

7. IVD-specific Issues

8. Over-arching & Cross-cutting Priorities

Each of the above priority areas has a list of ‘projects’ where work is needed to be done. Each project is assigned to one or more Commission working groups and assigned a priority rating (high, medium or low). The Roadmap takes into account stakeholder feedback which was given to a previous version of the draft Roadmap, including considerable feedback by MedTech Europe.

As a next step, each of the Commission working groups will now be asked to define a project plan specifying the timeframes and key milestones to deliver on the implementation plan. The detail in the CAMD Roadmap document is likely to evolve as the work programmes develop.

For the IVD sector, the majority of priorities related to IVDs have been captured within each of the 8 priority areas listed above, however MedTech Europe understands that the IVD-specific workstream allows issues specific to IVDs to be addressed or validated by the Commission working group on IVDs.