A road map which outlines the key challenges and steps for multiple technical work streams has been released 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. The aim is to improve cooperation in the medical devices network during implementation of new regulations. To help ensure improved protection for public health in the medical device sector, the overall objective is to implement and achieve an efficient, reliable and secure regulatory system.
Within the road map the implementation work has been divided into eight categories, with activities, the priority levels and recommended responsible partners and owners stated. The eight categories 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
Workshops held at the CAMD meetings in Amsterdam in June 2016 and in Bratislava in October 2016, helped identify the objectives outlined and the key implementation challenges for each technical work stream.
The road map says “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.”
Some examples of high priority activities include: clinical work evaluation package; guidance on classification for IVDs with practical examples; guidance on requirements for vigilance reporting and developing and agreeing on terminology for MD/IVD Adverse Nomenclature and patient harm.
The release of the road map comes as EU notified bodies are getting ready for a 26 November deadline, thus declaring their intentions to apply for designation as application and implementation of the regulations progresses.
To view the priorities for implementation of MDR and IVDR, and to read the road map in greater detail, please click here.