The new EU MDR represents a considerable change from the directives it replaced. During this course, you will learn about the new requirements in the EU Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance.

You will also learn how to plan an efficient implementation of the new regulation.

The British Academy for Training and Development offers this course to the following categories:

• Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing.
• Who work for manufacturers that market devices.

After completing the program, participants will be able to master the following topics:

• Describe the structure of the MDR.
• Learn the objectives of the MDR.
• Identify the impact of the MDR requirements on economic operators.
• Understand the different regulatory requirements through the life-cycle of a device (premarket, design and development, product realization, and postmarket).
• The necessary steps to follow the MDR.

• 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