EU-Medical Device Regulation Compliance Workshops

DAY 1
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 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 14971:2019 Part B – Implementing the Article 120 Transition MDD certificates MDR elements The Notified Body Managing the system The EUDAMED delay 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 Operators
10:30 a.m. – 10:45 a.m.	Morning Break
10:45 a.m. – 12:00 p.m.	Part D – The Quality Management System (QMS) Requirements from the MDR Linkage to ISO 13485:2016 The role of CEN/TR 17223:2018 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 from the MDR/IVDR Linkage to ISO 14971:2019 Changes from EN ISO 14971:2012 Exercise E1 – Elements of the RMS
2:15 p.m. – 2:30 p.m.	Afternoon Break
2:30 p.m. – 5:00 p.m.	Part F – The Postmarket Surveillance System (PMSS) Requirements from the MDRIVDR Clinical/performance evaluation and updates Postmarket clinical/performance follow-up Linkage to risk management Vigilance Trend reporting Field safety corrective actions Exercise F1 – Elements of the PMSS
5:00 p.m.	Session Wrap-up, End of Day One


Day 2
8:00 a.m. – 8:30 a.m.	Continental Breakfast
8:30 a.m. – 10:00 a.m.	Part G – Unique Device Identification (UDI) The role of UDI The basic UDI-DI Application to devices and packaging UDI and the declaration of conformity The EU database for UDI Exercise G1 – Unique Device Identification Part H – Device Classification Definitions for the classification rules Applying the classification rules Attributes in addition to the device class Exercise H1 – Device Classification
10:00 a.m. – 10:15 a.m.	Morning Break
10:15 a.m. – 12:00 p.m.	Part I – 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 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 harmonized standards Role of common specifications Exercise J1 – General Safety and Performance Requirements
2:15 p.m. – 2:30 p.m.	Afternoon 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 person responsible 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 Declaration of conformity The EU database Exercise L1 – Declaration of Conformity
4:30 p.m.	Workshop Completed

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/IVDR 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/IVDR. In particular, it looks at the role of CEN/TR 17223:2018 in mapping the EU-MDR/IVDR 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/IVDR. In particular the exercise looks at the relationship between ISO 14971:2019 and the EU-MDR/IVDR 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/IVDR system. Participants may 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/IVDR classification rules. Participants may 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 may bring information for a device their company markets with the CE Mark.

Exercise J1 – General Safety and Performance Requirements

This exercise gives participants an opportunity to understand how some of the EU-MDR/IVDR requirements differ from the MDD/IVDD Annex I requirements.

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 postmarket surveillance.

Exercise L1 – Declaration of Conformity

This exercise provides participants an opportunity to identify the required elements of a declaration of conformity. Participants may bring information for a device their company markets with the CE Mark.

Course I | Course II | Course III

WHO WILL BENEFIT

Quality Managers/Engineers
Risk Managers
Regulatory Affairs
Design Engineers
Supply Chain Managers
Production Managers/Engineers
Document Control Specialists
Marketing Managers
Clinical Managers
Clinical Evaluation Specialists
Export Compliance Manager