sitem Center for Translational Medicine and Biomedical Entrepreneurship

Standalone Modules

Module 2 - EU Medical Device Regulations Part A

 

Content

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

After successful completion of this module, participants have an understanding of 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. They also know the differen-ces between medical devices, in-vitro diagnostics, cosmetics and pharmaceuticals. Furthermore, they are aware of the roles and responsibilities of the various MDR key stakeholders and the concept of risk based product classification and impact on conformity assessment for market approval. 

Learning content

To achieve this, this module contains an introduction to medical device regulation, an overview and structure of the European Medical Device Regulation, economic operator, an overview about Traceability: Codes and Eudamed, insight into the Siwss National Regulatory System, device description and classification with an non-medicinal purpose, and conformity assessment based on classification. 

Start & Duration

2020: 14 September 2020
2021: TBC

The completion of this module takes approximately 14 weeks.

Credits

6 ECTS

Fee

The cost of this standalone module is 6'300.– SFr.

Reference

03.002

 

Module Leaders

Founder of meditec Consulting

Sandra Soniec

Sandra Soniec holds a degree in Biomedical engineering and has 20+ experience in the healthcare and life sciences regulatory environment, providing technical and expert support to start-ups and global players. In 2004, Sandra founded meditec Consulting, a consulting firm providing regulatory affairs and quality affairs services and solutions with focus on medical devices, in vitro diagnostics and combination products.

Independent Consultant

Dr. Jürgen Berndt

Jürgen Berndt has more than 30 years of experience in regulated industries including 18 years with 3M, where he was the European lead of the Quality and Regulatory functions for 8 years. He retired from his employment in various Regulatory Affairs leadership roles in May 2020 and now shares his knowledge and experience as a lecturer of the Medical Device Regulatory Affairs and Quality Assurance study program at the University of Bern.