The new regulation on medical products has entered into force as from 2017. All manufacturers of medical products must familiarize themselves with the new requirements. The regulation has far-reaching implications and affects all classes of medical products.

Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The new scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our seminar, you will gain a compact overview to align your company with the new requirements of 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).