20 – 21 May 2026: EU Medical Device Regulation (EU MDR 2017/745)

EU Medical Device Regulation (EU MDR 2017/745)

DATE: 20 & 21 May 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

INTRODUCTION
The EU Medical Device Regulation (MDR) 2017/745, published on 5 May 2017, introduced a comprehensive framework for regulating medical devices within the European Union. This regulation replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC), marking a significant shift toward more stringent and harmonized requirements.

This updated regulation outlines detailed requirements for economic operators — including manufacturers, authorized representatives, importers, and distributors — as well as for notified bodies. In addition to reinforcing existing rules, the EU MDR introduces new and updated classification criteria for medical devices, reflecting the evolving landscape of healthcare and medical technology, and patient safety.

This course will guide participants through the intricacies of the MDR, ensuring they are equipped with the knowledge to navigate the regulatory landscape effectively.

COURSE OBJECTIVES
After participating in the training, you will be able to understand:

• The structure of the EU Medical Device Regulation (EU MDR).
• The general obligations of economic operators.
• The importance of appointing a Person Responsible for Regulatory Compliance, and who can be appointed to the role.
• The additional rules in the EU MDR for medical devices classifications.
• The requirements for risk management process and Technical Documentation (Annex II and III of the EU MDR).
• The requirements for clinical investigation and evaluation.
• The different assessment route in accordance with Article 52.

COURSE OUTLINES
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 classification rules
5. Risk management and Technical Documentation
6. Clinical investigation and evaluation
7. Conformity assessment procedures