sitem-insel AG

M2 - EU Medical Device Regulations Part A

Module leaders: Sandra Soniec, Meditec-consulting
Dr. Jürgen Berndt, Independent Consultant



Date and Credits

Start: 14.09.2020

Duration: 14 Weeks

6 ECTS

Module 2 introduces the regulatory landscape and the European Medical Device Regulations (MDR). It focusses on the structure, interpretation and application of the MDR and includes a complex study of medical device classification.


Learning objectives

  • To understand the structure of the  Medical Device Regulation, EU 2017/745, (MDR) and important changes since release of the first EU Medical Device Directive 93/42/EEC
  • To understand the differences between medical devices, invitro diagnostics, cosmetics and pharmaceuticals.
  • To understand roles and responsibilities of the various MDR key stakeholders
  • To understand the concept  of risk based product classification and impact on conformity assessment for market approval.

Learning content

  • Introduction to medical device regulation
  • Overview and structure of the European Medical device Regulation (MDR)
  • Economic operators
  • Traceability: Codes and Eudamed
  • The swiss national regulatory system
  • Device description and classification with a non-medicinal purpose,
  • Conformity assessment based on classification