The New EU Medical Device regulation

The new MDR main changes

• Main updates
• Transition periods
• Effect on medical device manufacturers
• Regulatory landscape

Notified Bodies under the New MDR

• Effect on NBs
• When will NBs begin conformity assessment against the new Regulation?
• Main effect on medical device manufacturers

Impact of the MDR on Quality Management Systems (QMS)

• When do I need to update my QMS?
• What main points need to be considered?
• Effect on medical device manufacturers

Technical Documentation

• Class I and IIa devices
• Effect on class IIb devices
• Class III devices

CASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercises

Wrap up of day 1 & Q&A's

Clinical aspects and testing

• Class I and IIa devices
• Effect on class IIb devices
• Class III devices

Periodic Safety Update reports

• Content of PSUR
• Frequency

Common Specification (CS)

Common Tech Specifications

Combination Products

• Definitions
• Requirements
• Technical documentation

CASE STUDY 2 - Including a walkthrough of expected outcomes for all case study exercises

Wrap up of day 2 & Q&A's