The purpose of this training is to clarify the 2017/745 MDR Medical Device Regulation requirements and to share information on how these requirements should be met. The training will be carried out through sample documents and records.

Exhibitor Profile

Employees and managers of organizations liable to comply with the 2017/745 MDR directive, personnel working in organizations partnering with Medical Device manufacturers (For example, critical suppliers, authorized representatives, distributors, dealers, etc.)

What will I learn?

After completing this training you will be able to:

  • 2017/745 MDR content and fundamentals
  • Classification / reclassification of products
  • Non-medical products covered by the 2017/745 MDR
  • 2017/745 MDR Annex 1 General Safety and Performance Requirements (GSPR)
  • Conformity Assessment Route by risk class, validity of 93/42/EEC MDD Certification, transition period requirements
  • technical documentation
  • Requirements for different actors (eg Manufacturers, Distributors, EU Representatives, Dealers, Service Partners, etc.)
  • The role of the person responsible for the legislation
  • EUDAMED Database
  • UDI (Unique Device ID)
  • Declaration of conformity

The medical device industry is a complex and difficult industry that only those with industry experience can understand and solve. Our team of professional consultants has the skills and talent to address these challenges in depth and create product-specific solutions.
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