EU Medical Device Regulation MDR  (2017/745)

Agenda

Module 1: Introduction to the EU-MDR 

                         o History of the EU-MDR

                         o Purpose of the EU-MDR

                         o Structure of EU-MDR

                         o Key Terminology

                         o Key EU-MDR changes

Module 2: Device Classification

                         o Non-Medical devices

                        o What is a device?

                        o Devices in scope

                        o Devices out of scope

                        o Non-Medical devices

Module 3: Placing a Device on the Market 

                       o Overview of Chapter II

                       o Articles 5-9

                       o Economic Operator & PRRC Responsibilities

                       o Articles 16-24

Module 4: Device Classification 

                      o Overview of Annex VIII

                      o Class Types

                      o Classification Rules

Module 5: Routes To Conformity 

                     o Overview of Conformity Annexes

                     o Annex IX

                     o Annex X

                     o Annex XI

                     o Custom Made Devices

                     o Notified Body Articles & Annexes

Module 6: Risk Management 

                    o Overview of Annex I

                    o Chapter I General Requirements

                    o Risk Management (ISO 14971, Chapter II Design &
                       Manufacture

                    o Chapter III Device Information

Module 7: Clinical Evaluation 

                    o Overview of the Clinical Evaluation requirements including
                       Article 61-62 and Annex XIV

Module 8 : PSUR 

                       Overview of the requirements 

Module 9: Post Market Surveillance & Vigilance 

                        Overview of PMS Articles 83-86

                  Overview of Vigilance Articles 87-89

Module 10: Technical Documentation, UDI and Eudamed 

                         Annex II and Annex III 

                         Technical documentation

                         Unique Device Identification (Annex VI)

                         UDI Timelines

                          Overview of Eudamed

Learning Objectives                                                                                                                      
The new EU Medical Device Regulation (MDR 2017/745) replaced on 21-May-2021 the EU Medical Device Directive (MDD 93/42/EEC) which has been the medical device regulatory framework for CE mark and commercialization in all countries of the EU during the last 27 years. 

This is a big regulatory change that will directly impact thousands of medical device companies worldwide currently placing or planning to place their products onto the EU market.

The course will provide an in-depth knowledge of the new MDR, divided into several different modules.