Day1

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:30 a.m.

Part A – Overview of the Regulations

  • Introductions
  • Reasons for Change
  • Structure of the Regulations
  • Notified Bodies
  • Transition Timelines
  • Understanding Standards and Harmonization
  • EU version of ISO 13485:2016 and ISO 14971:2007

Part B – MDR Article 120 Transition

  • Status of the EU-MDR Implementation
  • Article 120 Transitional Provisions
  • Article 120
  • ISO 13485:2016 & CEN/TR 17223:2018
  • ISO 14971:2019
  • Status of NBs
  • Harmonized Standards & Common Specifications
  • Status of Eudamed
  • Manufacturer’s Potential Hurdles
  • Questions

Part C – 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 C1 – Person Responsible for Regulatory Compliance
  • Exercise C2 – Economic Operator

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Part D – The Quality Management System (QMS)

  • ISO 13485:2016 & CEN/TR 17223:2018
  • QMS Requirements
  • QMS Certificates
  • Exercise D1 – Elements of the QMS

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 p.m.

Part E – The Risk Management System (RMS)

  • Requirements
  • Description of Changes for ISO 14971:2019
  • The Process Flow in ISO 14971:2019
  • Annex I(3) The Risk Management System
  • Annex I(4) Risk Control Measures
  • Annex I(5) Use Error

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 5:00 p.m.

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

  • Risk Management
  • Benefit-Risk Determination (BRD)
  • Clinical Evaluation (CE)
  • Post-market Clinical Follow-up (PMCF)
  • Post-Market Surveillance
  • Post-market Surveillance Report (PMSR)
  • Periodic Safety Update Report (PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
  • Incident Reporting
  • Exercise F1 – Elements of the PMSS

5:00 p.m.

And much more!

 

Day1

8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 10:00 a.m.

Part G – Unique Device Identification

  • The Role of UDI
  • Basic UDI-DI
  • Application to Devices and Packaging
  • UDI and the Declaration of Conformity
  • The EU Database for UDI
  • Application Dates
  • ISO 13485:2016
  • Exercise G1 – UDI

Part H – Device Classification

  • Classification Rules
  • Applying the Classification Rules
  • Exercise H1 – Device Classification

10:00 a.m. – 10:15 a.m.

Break

10:15 a.m. – 12:00 p.m.

Part I – Conformity Assessment

  • MDR Conformity Assessment Methods
  • IVDR Conformity Assessment Methods
  • Exercise I1 – Conformity Assessment

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:15 p.m.

Part J – General Safety and Performance Requirements

  • Overview of the Requirements
  • Developing a Checklist
  • Role of the Harmonized Standards
  • Role of the Common Specifications
  • Exercise J1 – General Safety and Performance Requirements

2:15 p.m. – 2:30 p.m.

Break

2:30 p.m. – 4:30 p.m.

Part K – Technical Documentation

  • Understanding the Technical Documentation
  • Required Content
  • Maintaining the Technical Documentation
  • Role of the Authorized Representative
  • Exercise K1 – Technical Documentation in Annex II
  • Exercise K2 – Technical Documentation in Annex III

Part L – The Notified Body

  • Role of the Notified Body
  • MDR Conformity Assessment
  • IVDR Conformity Assessment
  • Declaration of Conformity
  • The EU Database
  • Exercise L1 – Declaration of Conformity

Summary, Conclusions, and Lessons Learned

4:30 p.m.

Adjourn Workshop

 

register

Description of the Exercises

Course 1 - Understanding and Implementing the EU-Medical Device Regulation

Exercise C1 – Person Responsible for Regulatory Compliance

This exercise analyzes the requirements to be a person responsible and allows each participant to determine if they could fill the role.

Exercise C2 – Economic Operators

This exercise provides an opportunity to classify economic operators in the EU-MDR and identify some of the relationships and requirements with the manufacturer.

Exercise D1 – Elements of the QMS

This exercise identifies required elements in the QMS and helps participants determine updates to satisfy the EU-MDR. In particular, it looks at the role of CEN/TR 17223:2018 in mapping the EU-MDR to ISO 13485:2016.

Exercise E1 – Elements of the RMS

This exercise identifies required elements in the RMS and helps participants determine updates to satisfy the EU-MDR. In particular the exercise looks at the relationship between the MDD content deviations in EN ISO 14971:2012 and the EU-MDR requirements.

F1 – Elements of the PMSS

This exercise identifies required elements in the PMSS and helps participants determine methods to meet those requirements.

Exercise G1 – Unique Device Identification

This exercise analyzes a device that satisfies the US UDI system to determine any additional work needed to satisfy the EU-MDR system. Participants are encouraged to bring UDI information for a device their company markets.

Exercise H1 – Device Classification

This exercise uses some example devices to provide an opportunity to apply the EU-MDR classification rules. Participants are encouraged to bring classification information for a device their company markets with the CE Mark.

Exercise I1 – Conformity Assessment

This exercise provides participants an opportunity to apply the conformity assessment requirements in Annex IX to an example device. Participants are encouraged to bring information for a device their company markets with the CE Mark following MDD Annex II.

Exercise J1 – General Safety and Performance Requirements

This exercise gives participants an opportunity to understand how some of the EU-MDR requirements differ from the MDD Annex I requirements. Participants are encouraged to bring information for a device their company markets with the CE Mark.

Exercise K1 – 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 K2 – Technical Documentation in Annex III

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

Exercise L1 – 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 I | Course II

Back to Top