Switching from the old EU medical device directives to the new Medical Device Regulation (MDR) isn't a paperwork update — it's a genuinely different set of expectations, covering everything from how products get classified to what counts as adequate clinical evidence. Companies that treat it as a minor administrative change tend to find out the hard way just how much has actually shifted.

This course at the Arab British Fellowship Training Academy walks through the updated requirements of the EU MDR in practical terms: quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and post-market surveillance. Participants leave with a clearer sense of how to plan an efficient rollout of the new regulation inside their own organisation.

Knowledge and Benefits

By the end of this course, participants will be able to:

• Understand how MDR requirements impact economic operators — manufacturers, importers and distributors alike.
• Describe the structure of the Medical Device Regulation (MDR) and understand its objectives.
• Comprehend the regulatory requirements that apply across a device's lifecycle, from premarket and design through product realisation and post-market stages.
• Follow the necessary steps to bring their organisation into compliance with the MDR.

Who Should Attend?

• Medical device professionals working in quality and regulatory affairs, design, and R&D within device manufacturers.
• Those working in risk management, post-market activities and manufacturing, particularly for companies that market devices.

Module 1: Getting Oriented — MDR Objectives and Classification Rules

• The objectives of the MDR.
• Device classification and the conformity assessment route under the MDR.

Module 2: Building the Compliance Foundation

• Quality management system requirements in the MDR.
• Technical documentation requirements in the MDR.

Module 3: Clinical Evidence and Product Traceability

• Clinical evaluation process requirements in the MDR.
• UDI and traceability requirements in the MDR.

Module 4: Staying Compliant After Launch

• Post-market surveillance under the MDR.
• Reporting requirements in the MDR.

Module 5: Risk, Audits and the Product Lifecycle

• The lifecycle of products, linked to risk management and clinical evidence.
• The impact of auditing under the MDR.