The HMA Core Group for Medical Devices has the following tasks:
- Prepare an action plan to
Agree and prioritise short and medium term challenges and opportunities as part of practical application of new EU Regulations on medical devices
(a) Enhancing EU mechanisms (process, system, resource) to coordinate and ensure safety issues relating to medical devices are addressed at European level in an effective and timely manner.
(b) With respect to medical device certification, reinforce mechanisms for system capacity and readiness and identify potential certification delays and challenges by working in close collaboration between competent authorities, the EU Commission and notified body representative groups.
(c) Establishing tangible supports for safe and timely innovation of new medical technologies
- Address longer term development of the regulatory system and activities to ensure consistency, predictability, sustainability and confidence.
(a) Create a proposal to outline and agree the core strategic priorities and goals for the EU regulatory system for medical devices
(b) Analyse the potential implications of new legislation and legislative proposals (such as the extension of the EMA mandate, the AI Regulation) for the medical devices regulatory system
(c) Examine models and detail options as to how the regulatory system could be further developed in the next legislative iteration to ensure safety, consistency and sustainability.
- Oversee the implement action plan in close collaboration with the MDCG, CAMD, EU Commission and the HMA.
- Reinforce support and influence to the medical device network and associated coordination and working groups to achieve their objectives in line with agreed strategic priorities.
- Build partnership with regular updates to plenary & liaison between HMA, MDCG,CAMD and the European Commission.
The work of the group will take into consideration work already performed by CAMD when performing its tasks with a view to avoid duplication of work.