Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

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

Module 2 starts in September each year.
The completion takes approximately 12 weeks.

Credits

6 ECTS

Fee

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

Reference

03.002

Module Leaders

Regulatory Affairs Director at Decomplix AG

Helena Lacalle

Helena Lacalle is a Regulatory Affairs professional with 25+ years of experience in strictly regulated industries, mainly medical devices and pharmaceuticals. She holds a pharmacy degree from the University of Barcelona, and a master degree in statistics from the University of Neuchatel, Switzerland. In January 2020, Helena joined Decomplix AG, a regulatory consultancy company that also offers Swiss Authorized Representative (CH-REP) services, where she is the Regulatory Affairs Director and simultaneously acts as Person Responsible for Regulatory Compliance (PRRC) for Decomplix’ CH-REP role.

Former Global Lead of Quality and Regulatory Functions at Pall Corporation

Heike Idink

Heike Idink has 30+ years of experience in regulated industries including 13 years with Pall Corporation, where she was the global lead of the Quality and Regulatory functions. She contributed to further improvement of a harmonized EU medical device legislation working for more than 15 years in various trade associations in Germany, Switzerland and at European level. She received a Diploma of Mineralogy from the RWTH Aachen University, Germany, a PhD of Natural Sciences from Penn State University, USA / RWTH Aachen University, Germany, and a Master of Business Law from FFHS, Switzerland.

Founder of meditec Consulting

Sandra Soniec

Sandra Soniec holds a degree in biomedical engineering and has 25+ experience in the healthcare and life sciences regulatory environment, providing technical and expert support to start-ups and global players. In 2004, she 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. Sandra began her career in 1999 as Regulatory Affairs Specialist at Disetronic Medical Systems, where she built up the regulatory affairs team. In her current role, she supports teams developing RA Strategies for accessing new markets, understanding complex regulatory and quality requirements and managing audits, inspections and changes in regulations.