Since 2017, the new regulation on medical products has been in force, requiring all manufacturers to understand its comprehensive requirements. The regulation impacts all classes of medical products, introducing significant changes in product classification, basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. Notable updates include a new scrutiny process, reprocessing requirements, and the European Eudamed database. The British Academy for Training and Development offers this seminar to provide a clear overview, helping participants align their organizations with the Medical Device Regulation (MDR).

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

• Consultants in the medical device industry.
• Newcomers in the medical device industry.
• Personnel in quality management.
• Expert and executive personnel.

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

• Gain the new legal requirements of the Medical Device Regulation (MDR).
• Receive an overview of the efficient and safe manufacture of medical products in accordance with the Medical Device Regulation (MDR).
• Gain an understanding of your responsibilities and obligations as a manufacturer, importers and distributers of medical devices.

• Fundamentals of the Medical Device Regulation (MDR).
• Classification of Products.
• Technical Specifications.
• Content Requirements for Technical Documentation.
• New Basic Requirements
• Post Market Surveillance.
• Scrutiny Procedure.
• Validity of Conformity Assessment and Certification, Transition Periods.
• Role of Contact Person for Regulatory Compliance.
• Eudamed Database.
• UDI (Unique Device Identification).