Conference Program

• Legal background
• QMS requirements
• PRRC

• New classification rules
• Devices up-classified under the MDR

- Differences in the Conformity Assessment Procedures
- Strategic considerations

• New labeling requirements
• Link to the Risk Management update

• Changes between MDD and MDR requirements
• Keeping the TD aligned and up-to-date
Navigating MDR Changes and Reducing Redundancies. Insights on essential documentation elements, MDD to MDR transition, and conquering challenges with digital solutions for streamlined updates.


- Where is EUDAMED now?
- When is it binding to use EUDAMED?
- Is EUDAMED affected by the MDR extension?

- General UDI requirements
- UDI requirements for systems comprised of multiple devices

• Strategies for devices transitioning from MDD to MDR
• Considerations for a device to be a well-established technology

• Structure of a search protocol and report
• Appraisal and analysis of search results

• EU GDPR
• Legal and regulatory considerations

• Changes in vigilance requirements
• Reporting to CAs

• When is a general and when a specific PMCF required
• PMCF covering device lifetime

• PSUR Timelines
• Notified Body experience with initial PSUR submissions
• Granularity of an SSCP