Congress Program
08:00
Registration
08:50
Conference Opening & Welcome
Bassil Akra, Conference Chair
09:00
Session 1: General Requirements and Classification
09:00 - 09:30
MDR Implementation and Legal Requirements

Glenda Marsh
Senior Director, EMEA Regulatory Affairs, Johnson & Johnson, Switzerland
Show Summary
• Legal background
• QMS requirements
• PRRC
09:30 - 10:00
Changes in the Classification System

Elizabeth Gfoeller
Corporate Director Regulatory Affairs, MED-EL, Austria
Show Summary
• New classification rules
• Devices up-classified under the MDR
10:00 - 10:30
Strategic Considerations for the Conformity Assessment

Bassil Akra
Founder and CEO Akra Team, Germany
Show Summary
- Differences in the Conformity Assessment Procedures
- Strategic considerations
10:30
Coffee Break, Networking and Visit the Exhibition
11:00
Workshop 1
- Workshop in different break-out groups, led by the presenters of Session 1 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Tasks will be identical for each group but with different examples
- Group will ‘develop’ one device including classification and regulatory strategy
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
12:30
Lunch Break, Networking and Visit the Exhibition
13:30
Session 2 – Conformity Assessment Plan
13:30 - 14:00
Labeling Changes under the MDR

Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
Show Summary
• New labeling requirements
• Link to the Risk Management update
14:00 - 14:30
Content of the Technical Documentation

Morwan Choli
Executive Vice President R&Q, Occlutech, Japan
Show Summary
• Changes between MDD and MDR requirements
• Keeping the TD aligned and up-to-date
14:30 - 14:45
EUDAMED Update (
Pre-Recorded)


Richard Houlihan
CEO, EirMed, Belgium
Show Summary
- Update on EUDAMED timelines
- Experience with voluntarily available modules
14:45 - 15:00
UDI Requirements

Daniel Rubisoier
Regulatory Affairs Specialist, TÜV SÜD, Austria
Show Summary
- General UDI requirements
- UDI requirements for systems comprised of multiple devices
15:00
Coffee Break, Networking and Visit the Exhibition
15:30
Workshop 2
- Workshop in different break-out groups, led by the presenters of Session 2 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Participants will develop a draft IFU and draft TD structure for their developed device
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
17:00
End of Day One
08:30
Registration
09:00
Session 3: Clinical Evaluation
09:00 - 09:30
Planning of the Clinical Evaluation Including Clinical Strategies

Rachel Mead
Clinical Regulatory Lead, BSI Group, UK
Show Summary
• Strategies for devices transitioning from MDD to MDR
• Considerations for a device to be a well-established technology
09:30 - 10:00
Relevant Aspects of a Scientifically Valid Literature Search

Shelley Jambresic
Senior Clinical Evaluation Manager, Geistlich Pharma, Switzerland
Show Summary
• Structure of a search protocol and report
• Appraisal and analysis of search results
10:00 - 10:30
Medical Device Software and Cybersecurity

Eric Vollebregt
Partner, Axon Lawyers, Netherlands
Show Summary
• EU GDPR
• Legal and regulatory considerations
10:30
Coffee Break, Networking and Visit the Exhibition
11:00
Workshop 3
- Workshop in different break-out groups, led by the presenters of Session 3 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Based on the example device and the draft CEP they would decide on the clinical strategy
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
12:30
Lunch Break, Networking and Visit the Exhibition
13:30
Session 4: Post-Market Requirements
13:30 - 14:00
PMS and Vigilance Requirements

Danielle Giroud
Founder and CEO, MD Clinicals, Switzerland
Show Summary
• Changes in vigilance requirements
• Reporting to CAs
14:00 - 14:30
General and Specific PMCF Activities

Matthias Fink
Senior Clinical Consultant, Akra Team, Germany
Show Summary
• When is a general and when a specific PMCF required
• PMCF covering device lifetime
14:30 - 15:00
PSUR and SSCP

Christoph Ziskoven
Clinical Expert Medical Devices, TÜV Rheinland, Germany
Show Summary
• PSUR Timelines
• Notified Body experience with initial PSUR submissions
• Granularity of an SSCP
15:00
Coffee Break, Networking and Visit the Exhibition
15:30
Workshop 4
- Workshop in different break-out groups, led by the presenters of Session 4 but depending on the number of participants other presenters will facilitate too
- 3 breakout groups planned
- Groups would develop draft PMCF Plan, PSUR and SSCP for their example devices
- 1h workshop time, group will work on examples
- 5 min presentation + 5 min discussion of the results per team to the auditorium
17:00
Conference Closing