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
