Fantásticas jornadas en las que tuvimos oportunidad de actualizarnos con las novedades de los reglamentos MDR e IVDR por expertos europeos, con la participación de la Comisión Europea, Medtech, EAAR, …
Nos hicimos una foto todos los miembros de EAAR
PROGRAMA
Monday, 24 February 2025
08:00-18:00 Registration
09:20-09:30 Conference Opening & Welcome Ludger Möller | Conference Chair
Session 1: Current State of Play in the Implementation of MDR & What’s Coming Next
09:30-10:00 State of the Play with More In-Depth Upcoming Policies Nada Alkhayat, Policy Officer at European Commission, Belgium
10:00-10:30 Proposal for the Revision of the EU MDR Erik Vollebregt, Partner, Axon Lawyers, The Netherlands
10:30-11:00 Position of MTE on the Proposal to Revise EU MDR Petra Zoellner, Regulatory Affairs (IVDR & MDR) Director, MedTech Europe, Belgium
11:00-11:30 Coffee Break, Networking and Visit the Exhibition One-to-One Meetings (11:00-11:20)
Session 2: Notified Bodies – MDR
11:30-12:10 Technical Documentation Compilation, Example of SaMD or Legacy Devices Virginie Siloret, Global Medical Devices Certification Manager, SGS, France
12:10-12:50 MDR Journey: Challenges, Opportunities and Recommendations Bassil Akra, CEO and President of AKRA TEAM, Germany
12:50-13:00 Discussion / Q&A
13:00-14:00 Lunch Break, Networking and Visit the Exhibition One-to-One Meetings (13:00-13:30)
Session 3: State of Play and NB Expectations – IVD
14:00-14:40 State of Play Olga Tkachenko, Policy Officer, European Commission, Belgium4 Congress Program
14:40-15:20 How to Prepare for your IVDR Transition for Successful CE-Marking Daphne Hessels, Project Manager IVD and Medical Devices, DEKRA Certification, Netherlands
15:20-15:30 Discussion / Q&A
15:30-16:00 Coffee Break, Networking and Visit the Exhibition One-to-One Meetings (15:30-15:50)
Session 4: Supply Chain Roundtable (Importers, Distributors)
16:00-17:00 How they Implemented MDR/IVDR Requirements Volker Lücker, Editor, Deutscher Apotheker Verlag, Germany BSI on Article 16 Albert Roossien, Regulatory Lead at Medical Devices Notified Body BSI Group The Netherlands
Session 5: Manufacturer Success Story
Moderator: Claire Murphy
17:00-17:30 Success Story in Implementing MDR Giulia Girola, Regulatory Affairs Specialist, Materialise, Belgium
17:30-18:00 Success Story in Implementing IVDR Ilinca Visanoiu, Regulatory Affairs Manager MRC Holland, Netherlands
18:00 Networking Cocktail
Tuesday, 25 February 2025
08:30-16:00 Registration
08:50-09:00 Welcome Session Ludger Möller | Conference Chair
Session 6: Digital Era & Medical Devices
09:00-09:30 Bringing the EU AI Act to the Boardroom Koen Cobbaert, Senior Manager – Quality, Standards and Regulations at Philips, Belgium
09:30-10:00 AI Act Nada Alkhayat, Policy Officer at European Commission, Belgium
10:00-10:30 Authorized Representive Under AI Act Ludger Möller, EAAR Chairman, President, MDSS GmbH, Germany
10:30-11:00 Coffee Break, Networking and Visit the Exhibition One-to-One Meetings (10:30-10:50)
Session 7: Vigilance & PMS
11:00-11:30 Eudamed Vigilance Module, Testing from a CA Perspective Marcel Schijf, Medical Technology Health and Youth Care Inspectorate, Ministry of Health, Welfare and Sport, Netherlands
Session 8: Clinical Data Requirements and Clinical Investigations
11:30-11:50 Strategic Approaches to Clinical Data Requirements in the EU and US Maria Donawa, M.D., President, Donawa Lifescience Consulting, Italy
11:50-12:10 The Challenges of Navigating Performance Study Applications/Notifications in Europe and their Impact on Pharma Clinical Trials Kirsten Van Garsse, Regulatory Affairs Manager & Director Authorized Representative Operations, Qarad, Belgium6 Congress Program
12:10-12:30 Is it a Drug or a Device? How to Use the Authorities to Find the Best Possible Clinical Investigation Design and Pathway Søren Underbjerg, Team Lead Clinical Development and Market Access, Qmed, Denmark
12:30-14:00 Lunch Break, Networking and Visit the Exhibition One-to-One Meetings (12:30-13:00)
Session 9: UK & Switzerland
Moderator: Claire Murphy
14:00-14:30 Swiss, FDA Approvals Hasmik Kirakosyan, Consultant, MDSS, Germany
14:30-15:00 UKRPA on UK State of Play, Recognition of Devices Mika Reinikainen, UKRPA Chairman, Managing Director, Abnovo, UK
15:00-15:30 Q&A for all Speakers and Conference Closing Remarks
15:30-16:00 End Coffee Break, Networking and Visit the Exhibition One-to-One Meetings (15:30-15:50)
