MDR Essentials: A Practical Overview for Medical Device Manufacturers (Online / Remote)
1Summary
Manufacturers still working from old assumptions about EU medical device compliance have had a wake-up call since 2017, when the new Medical Device Regulation came into force. It reaches every class of medical product, not just the high-risk ones, and it changed the rules around classification, basic requirements, technical documentation, clinical evidence, market surveillance and quality management systems all at once. A few pieces are entirely new too — an added scrutiny process, reprocessing requirements, and the European Eudamed database among them.
This seminar from the Arab British Fellowship Training Academy is built to give a clear, practical overview of all of that, helping participants align their own organisation with the Medical Device Regulation (MDR) rather than trying to piece it together from scattered sources.
2Objectives and target group
Knowledge and Benefits
By the end of this seminar, participants will be able to:
- Grasp the new legal requirements introduced by the Medical Device Regulation (MDR).
- Understand what efficient, safe manufacturing of medical products looks like in practice under the MDR.
- Know their responsibilities and obligations as a manufacturer, importer or distributor of medical devices under the new framework.
Who Should Attend?
- Consultants advising within the medical device industry.
- Newcomers to the medical device industry who need a solid foundation.
- Quality management, expert and executive personnel responsible for compliance oversight.
3Course Content
Module 1: What Changed Under MDR
- The new basic requirements introduced under the MDR.
- The scrutiny procedure.
Module 2: Classifying and Documenting Your Product
- Fundamentals of the Medical Device Regulation (MDR).
- Classification of products, and technical specifications.
- Content requirements for technical documentation.
Module 3: Market Surveillance and Traceability Tools
- Post-market surveillance.
- The Eudamed database.
- UDI (Unique Device Identification).
Module 4: Certification, Transition and Compliance Roles
- Validity of conformity assessment and certification, and transition periods.
- The role of the contact person for regulatory compliance.