Mondays for Future: Updates and Plans for 2023-2024

In this series of Mondays for Future meetings spanning from November 2023 to January 2024, key topics such as EUDAMED delays, Capacity JAMS 2.0, and collaborative efforts with various agencies were discussed. Plans include proposing common messages at EPSCO meetings, enhancing collaboration through action plans, and organizing events like the PRRC annual summit. The focus shifts to initiatives in December, kicking off meetings, discussing priorities for 2024, and preparing for the CAMD plenary meeting under the Belgium Presidency. The new year brings new challenges and goals for 2024, touching on legislative modifications, EUDAMED rollout, and innovation in healthcare. Throughout these sessions, efforts are made to ensure transparency, strengthen collaboration, and address pressing regulatory issues in the medical device industry.

• Future
• Updates
• Plans
• Collaboration
• Healthcare

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1. Mondays for future Build together

2. Mondays for future : November 2023 Welcome and hot topics EUDAMED delays, EY review, Capacities JAMS 2.0 : On your marks, get set . CEG meeting with Heads of agencies Share state of play and concerns about implementation Proposal for a common message for the next EPSCO meeting 30th Nov Common goals, Tranparency, Eudamed, MD in the agenda of the next Commission Increase collaboration with an action plan to tackle short and medium term issues Ask for meeting with Sandra Gallina (HMA Core Group) Flora Giorgio (CEG) Call for support of CAMD members Proposition of a short talk Call for interest : Short talk topics Participation at the Team PRRC annual summit Strasbourg 16-17 nov 2023

3. Mondays for future : December 2023 Welcome and hot topics EPSCO meeting : EUDAMED delays JAMS 2.0 : Kick-off meetings (WP1 / WP5 / WP6 / WP7); Communication activities HMA Core group/ CAMD insipiration paper Share state of play and concerns about implementation : base for 2024 actions and priorities Discussions at 16 th meeting HMA Core Group How to going further at CAMD level Proposal for a short talk in January CEG agenda Virtual WS December 14th : In person WS Brussels 10th 11 th Core objectives review, TOR/ROP TF, Be Presidency CAMD plenary meeting preparation CAMD agenda for 2024 Call for interest : Short talk topics

4. Mondays for future : January 2024 Happy new year !! Welcome and hot topics Congratulations to our Belgium colleagues and the new presidency 2024 a decisive year for the new regulatory system May/ September deadline for MD, Class D submission and EURL entry into force Remaining challenges for innovation EU4health Governance and innovation Guidances maintenance CEG agenda Meeting with Flora Giorgio with chair and cochair Strengthen collaboration with Commission In person WS Brussels 10th 11 th Core objectives review, TOR/ROP TF CAMD plenary under Belgium Presidency in Ghent CEG objectives for 2024 : Access to Meetings minutes for CAMD members An agenda shared with you on website EPSCO meeting follow up New legislative modification EUDAMED gradual roll out IVD postponement Discontinuation of MD How to get clear picture of the situation Place of the CAMD network Call for interest : Short talk topics