Training Course in Implementing the EU’s Medical Device Regulation
1Summary
The new EU Medical Device Regulation (MDR) marks a significant shift from the previous directives. This course at the Arab British Fellowship Training Academy will cover the updated requirements of the EU MDR, focusing on essential topics such as quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and post-market surveillance. Participants will also gain insights into planning an efficient implementation of the new regulations.
2Objectives and target group
The Arab British Fellowship Training Academy offers this course for medical device professionals involved in quality and regulatory affairs, design, risk management, post-market activities, R&D, and manufacturing, particularly those working for manufacturers that market devices.
Upon completing the program, participants will be equipped to:
- Describe the structure of the Medical Device Regulation (MDR).
- Understand the objectives of the MDR.
- Identify how MDR requirements impact economic operators.
- Comprehend the various regulatory requirements throughout a device's lifecycle, including premarket, design and development, product realization, and post-market stages.
- Follow the necessary steps to comply with the MDR.
3Course Content
- The objectives of the MDR.
- Quality management system requirements in the MDR
- Device classification and conformity assessment route in the MDR
- Technical documentation requirements in the MDR
- Clinical evaluation process requirements in the MDR
- UDI and traceability requirements in the MDR
- Postmarket surveillance.
- Reporting requirements in the MDR
- Life-cycle of products linked to risk management and clinical evidence.
- Auditing impact of the MDR