Program
08:20-09:20
Registration
09:20-09:30
Conference Opening & Welcome
Ludger Möller | Conference Chair
09:30-11:00
Session 1: Current State of Play in the Implementation of MDR & What's Coming Next
09:00-09:30
Proposal for the Revision of the EU MDR
European Parliament TBC
10:00-10:30
State of the Play with More In-Depth Upcoming Policies, etc.
European Commission TBC
10:30-11:00
Position of MTE on the Proposal to Revise EU MDR
MedTech Europe TBC
11:00-11:30
Coffee Break, Networking & Visit the Exhibition
11:30-13:00
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 Owner of AKRA TEAM, Germany
12:50-13:00
Discussions / Q&A
13:00-14:00
Lunch Break, Networking & Visit the Exhibition
14:00-15:30
Session 3: State of Play and NB Expectations - IVDR
14:00-14:40
State of Play
Olga Tkachenko
Policy Officer, European Commission, Belgium
14:40-15:20
Companion Diagnostics, Combination Products
IVDR Notified Body
15:20-15:30
Discussions / Q&A
15:30-16:00
Coffee Break, Networking & Visit the Exhibition
16:00-17:00
Session 4: Supply Chain Roundtable (Importers, Distributors)
16:00-16:30
How they Implemented MDR/IVDR Requirements
Importer / Distributor TBC
16:30-17:00
BSI on Article 16
Alex Laan
Head of IVD Notified Body, BSI Group, Netherlands
Albert Roossien
Regulatory Lead, BSi, Netherlands
17:00-18:00
Session 5: Manufacturer Success Story
17:00-17:30
Success Story in Implementing MDR
Non-EU Manufacturer
17:30-18:00
Success Story in Implementing IVDR
Non-EU Manufacturer
08:50-09:00
Welcome Session
Ludger Möller | Conference Chair
09:00-10:30
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
European Commission TBC
10:00-10:30
Authorized Representive Under AI Act
Ludger Möller
EAAR Chairman, President, MDSS GmbH, Germany
10:30-11:00
Coffee Break, Networking & Visit the Exhibition
11:00-12:00
Session 7: Vigilance & PM
11:00-11:30
Vigilance Module - EUDAMED
11:30-12:00
Vigilance State of Play & PMs
European Commission TBC
12:00-13:00
Session 8: Clinical Data Requirements and Clinical Investigations
12:00-12:20
Strategic Approaches to Clinical Data Requirements in the EU and US
Maria Donawa, M.D.
President, Donawa Lifescience Consulting, Italy
12:20-12:40
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, Belgium
12:40-13:00
Is it a Drug or a Device? How to Use the Authorities to Find the Best Possible Clinical Investigation Design and Pathway
Helene Quie
COO, Founder & Senior Principal Advisor, Qmed, Denmark
13:00-14:00
Lunch Break, Networking & Visit the Exhibition
14:00-15:30
Session 9: UK & Switzerland
14:00-14:30
Swiss, FDA Approvals
Swiss MedTech TBC
14:30-15:00
TBD
ABHI TBC
15:00-15:30
UKRPA on UK State of Play, Recognition of Devices
UKRPA TBC
15:30-16:00
Q&A for all Speakers and Conference Closing
