Mastering EU Medical Device Regulation

Day1

8:00 a.m. – 9:30 a.m.

Registration and Continental Breakfast

9:30 a.m. – 10:30 a.m.

Part A – Overview of the New Regulation

  • Reasons for Change
  • Summary of major changes from the MDD
  • Notified Bodies
  • Transition Period
  • Understanding Standards and Harmonization
  • EU Versions of ISO 13485:2016 and ISO 14971:2007

Part B – Obligations of the Manufacturer

  • Economic Operators
  • Single Registration Number
  • QMS, RMS, and PMS
  • CE Mark and Declaration of Conformity
  • UDI Requirements
  • Incidents and Field Safety Corrective Actions
  • Person Responsible for Regulatory Compliance
  • Product Liability Insurance
  • Exercise B1 – Person Responsible for Regulatory Compliance
  • Exercise B2 – Economic Operators

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Part C – The Quality Management System (QMS)

  • Requirements from the MDR
  • Linkage to ISO 13485:2016
  • The role of CEN/TR 17223:2018
  • QMS Certificates
  • Exercise C1 – Elements of the QMS

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 p.m.

Part D – The Risk Management System (RMS)

    • Requirements from the MDR
    • Linkage to ISO 14971:2007
    • Changes from EN ISO 14971:2012
    • Exercise D1 – Elements of the RMS

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 5:00 p.m.

Part E – The Post-market Surveillance System (PMSS)

  • Requirements from the MDR
  • Clinical Evaluation and Updates
  • Post-Market Clinical Follow-Up
  • Linkage to Risk Management
  • Vigilance
  • Trend Reporting
  • Field Safety Corrective Actions
  • Exercise E1 – Elements of the PMSS

5:00 p.m.

Session Wrap-up End of Day One

 

Day1

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

Part G – Device Classification

  • Definitions for the Classification Rules
  • Applying the Classification Rules
  • Attributes in Addition to the Device Class
  • Exercise G1 – Device Classification

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Part H – Conformity Assessment

  • Conformity Assessment Methods
  • Connecting the Device Class to the Conformity Assessment Paths
  • Attributes in Addition to the Device Class
  • Understanding Annex IX
  • Exercise H1 – Conformity Assessment

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 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

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 4:30 p.m.

Part J – Technical Documentation

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

 

Part K – The Notified Body

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

4:30 p.m.

Workshop Completed

 

 

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Course I | Course II

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