Understanding and Implementing EU Medical Device Regulation

Day1

8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 10:00 a.m.

Part A – Overview of the New Regulations

  • Reasons for Change
  • Summary of major changes from the MDD
  • Notified Bodies
  • Transition Period
  • EU Versions of ISO 13485:2016 and ISO 14971:2007
  • Exercise A1 – QMS and RMS Analysis

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

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

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

Part C The Quality Management System (QMS)

  • Requirements from the MDR
  • Linkage to ISO 13485:2016
  • QMS Certificates
  • Exercise C1 – Elements of the QMS

 

Part D The Risk Management System (PMS)

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

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

Part E The Post-market Surveillance System (PMSS)

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

4:30 p.m.

Session Wrap-up End of Day One

 

register

Description of the Exercises

Exercise A1 – QMS and RMS Analysis
This exercise matches selected sections from ISO 13485:2016 and ISO 14971:2007 to the corresponding requirement in the Medical Device Regulation to determine if the international standard would fulfill the MDR Requirement.

Exercise B1 – Person Responsible for Regulatory Compliance
This exercise analyzes the requirements to be a person responsible to allow each participant to determine if they could fill the role.

Exercise B2 – Economic Operators
This exercise provides an opportunity to classify economic operators in the EU-MDR, EN ISO 13485:2016, and US FDA frameworks

Exercise C1 – Elements of the QMS
This exercise identifies required elements in the Quality Management System, QMS, and helps participants determine any additional work needed to satisfy the new regulations

Exercise D1 – Elements of the RMS
This exercise identifies required elements in the Risk Management System, RMS, and helps participants determine any additional work needed to satisfy the new regulations

Exercise E1 – Elements of the PMSS
This exercise identifies required elements in the Post-market Surveillance System, PMSS, and helps participants determine any additional work needed to satisfy the new regulations

Course Binder Materials: 

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

 

Day 1 | Day 2

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