ARISE Plus Malaysia: Workshop on EU Regulation 2017/745 for Medical Devices (EU MDR) for Malaysian SMEs

Date: 21,22 and 23 September 2022
Time: 9.00am – 5.30pm (Registration starts at 8.30am)
Venue: Pullman Kuala Lumpur Bangsar Hotel,
No 1, Jalan Pantai Baharu, Jaya Tower 3, 59200 Kuala Lumpur

Mode of Training: In-person face-to-face training.

Delivery of Training: The training workshop shall be delivered in English.

Methodology
• Lecture
• Breakout Group Discussion
• Case study
• Quiz
• Pre-test and Post-test

Introduction

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-page 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.

Part 1: Beginner Level

 Course Outline

• Introduction and pre-test
• Background of the EU Medical Device Regulation and its structure
• Who shall comply with the EU Medical Device Regulation
• Quality management system and person responsible for regulatory compliance
• Medical device rules and classifications
• Snapshot on technical documentation
• Conformity assessment procedures
• Responsibilities of the manufacturer in monitoring the safety and performance of medical device in post market phase
• The EU Medical Device Regulation timeline
• Course summary
• Post-test and discussion

 Course Objectives

This course aims to give participants a brief introduction regarding the EU Medical Device Regulation and the course content outlined is to provide participants with:

• Introductory knowledge on the structure of the EU Medical Device Regulation
• Information on who shall comply with the EU Medical Device Regulation
• Knowledge on the Rules and Classifications of the medical devices
• Information on conformity assessment procedures

Course Benefits

Upon completion of this training, participants will: –

1. Be able to understand the purpose of the EU MDR
2. Be able to understand the basic structure of the EU MDR
3. Have the knowledge of the role and responsibilities of the economic operators
4. Have the knowledge on how medical devices are classified under the new EU MDR requirements

Part 2: Intermediate Level

 Course Outline

• Introduction and pre-test
• Background of the EU Medical Device Regulation and its structure
• The role and responsibilities of the economic operators
• Person responsible for regulatory compliance
• Medical device rules and classifications
• Basic UDI
• Risk management and in-depth technical documentation
• Clinical investigation and evaluation
• Conformity assessment procedures
• Implementing post market surveillance and vigilance system according to MDR
• Course summary, post-test, and discussion

 Course Objectives

This course aims to give participants in-depth knowledge regarding the EU Medical Device Regulation and the course content outlined is to provide participants 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 Benefits

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

1. The purpose and comprehensive 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