OVERVIEW

The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017, and it has replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It came into force on the 25th May 2017, and all the related and relevant manufacturers have three years transition period to comply with the EU MDR. However, the European Parliament has adopted and supported the European Commission’s proposal to postpone the effective compliance and application of the EU MDR to 26th May 2021 due to the Covid-19 outbreak.

The 175-pages document outlined regulatory requirements to the economic operators (a manufacturer, an authorized representative, an importer and/or a distributor) as well as the notified bodies. The EU MDR also outlined the Rules (with added Rules compared to the previous EU Medical Device Directive) for medical device classification purposes.

The EU MDR compliance is important and mandatory for all existing economic operators that involved in marketing medical devices in the EU market as well as all economic operators who wish to expand their medical device distribution into the EU market.

COURSE OBJECTIVES

This course aims to give delegatesin-depth knowledge regarding the EU Medical Device Regulation and the course content outlined is to provide delegates with information on:

• The structure of the EU Medical Device Regulation
•  Who shall comply with the EU Medical Device Regulation
• The Rules and Classifications of the medical devices
• The Technical Documentation (Annex II and III of the EU MDR)
• Clinical Investigation and Evaluation
• Conformity assessment procedures

COURSE OUTLINE

Day 1: 

Opening and introduction

1.          Background of the EU Medical Device Regulation and its Structure

2.          The role and responsibilities of the economic operators

3.          Person Responsible for Regulatory Compliance

4.          Medical device Rules and Classifications

5.          Risk Management and Technical Documentation

Day 2: 

Day 1 Recap

5.          Risk Management and Technical Documentation (Continue)

6.          Clinical Investigation and Evaluation

7.          Conformity assessment procedures

8.          Course summary

COURSE BENEFITS

Upon completion of this training, delegates will have the knowledge on: –

1. The purpose and structure of the EU MDR
2. Who should be the appointed the Person Responsible for Regulatory Compliance
3. Added Rules in the EU MDR for medical devices classifications
4. The requirements on Risk Management Process and Technical Documentation
5. The requirements on Clinical Investigation and Evaluation
6. The different assessment route in accordance to Article 52 – Conformity assessment procedures

TARGET AUDIENCE

This program is very useful to delegates who handles EU MDR compliance and actively involved in EU MDR compliance planning and execution. However, this program is not restricted only to Quality and Regulatory Affairs personnel, personnel from other functions such as Design and Production will be benefited from this program as well.