Understanding and Implementing EU Medical Device Regulation

Day2

8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:00 a.m.

Part F – Unique Device Identification

  • The Role of UDI
  • Application to Devices and Packaging
  • UDI and the Declaration of Conformity
  • The EU Database for UDI
  • Exercise F1 – Unique Device Identification

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Part G – Device Classification

  • Definitions for the Classification Rules
  • Applying the Classification Rules
  • Exercise G1 – Device Classification

 

Part H – Conformity Assessment

  • Conformity Assessment Methods
  • Connecting the Device Class to the Conformity Assessment Paths
  • Applying conformity assessment
  • Exercise H1 – Conformity Assessment

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part I – General Safety and Performance Requirements

  • Overview of the Requirements
  • Developing a Checklist
  • Role of Harmonized Standards
  • Role of Common Specifications
  • Exercise I1 – General Safety and Performance Requirements

 

Part J – Technical Documentation

  • Understanding the Technical Documentation
  • Require Content
  • Maintaining the Technical Documentation
  • Role of the Authorized Representative
  • Exercise J1 – Technical Documentation in Annex II
  • Exercise J2 – Technical Documentation in Annex III

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:15 p.m.

Part K – The Notified Body

  • Role of the Notified Body
  • Declaration of Conformity
  • The EU Database
  • Exercise K1 – Declaration of Conformity

4:15 p.m. – 4:30 p.m.

Summary, Conclusions, and Lessons Learned

4:30 p.m.

Adjourn Workshop

 

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Description of the Exercises

Exercise F1 – Unique Device Identification
This exercise analyzes a device that satisfies the US UDI system to determine any additional work needed to satisfy the EU system. Participants are encouraged to bring UDI information for a product their company markets.

Exercise G1 – Device Classification
This exercise uses some example devices to provide an opportunity to apply the EU-MDR or the EU-IVDR classification rules. Participants are encouraged to bring classification information for a product their company markets with the CE Mark.

Exercise H1 – Conformity Assessment
This exercise provides participants an opportunity to apply the conformity assessment requirements in the EU-MDR or EU-IVDR to an example product. Participants are encouraged to bring information for a product their company markets with the CE Mark.

Exercise I1 – General Safety and Performance Requirements
This exercise gives participants an opportunity to understand how some of the EU-MDR and EU-IVDR requirements differ from the corresponding requirements in the directives. Participants are encouraged to bring information for a product their company markets with the CE Mark.

Exercise J1 – Technical Documentation in Annex II
This exercise provides participants with an opportunity to understand the structure of the documentation required in Annex II Technical Documentation

Exercise J2 – Technical Documentation in Annex III
This exercise provides participants with an opportunity to understand the structure of the documentation required in Annex Technical Documentation on Post-market Surveillance

Exercise K1 – Declaration of Conformity
This exercise provides participants an opportunity to identify the required elements of a Declaration of Conformity. Participants are encouraged to bring information for a device their company markets with the CE Mark.

Course Binder Materials: 

  • Slides from PowerPoint presentations
  • Interactive exercise worksheets
  • Additional reseource materials

 

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