Second Workshop – Introduction to Regulatory Affairs in Medtech
Monday, 21th October 2019, 10:00 – 16:45,
ETH Zürich – Hönggerberg

This training provides you with the basics of regulatory affairs in Medtech with the focus on MDR and IVDR (Medical Devices and In-Vitro Diagnostic Medical Devices Regulation). Get an overview of the regulatory landscape, hear about the basic concepts and principles and get insight into the necessary steps but also pitfalls when bringing a Medtech product to the market. Discuss with the experts.

Training Objective

  • Get an overview of the regulatory landscape and regulatory stakeholders in Medtech
  • Understand the major principles, concepts and processes
  • Learn to sequence the necessary steps and build awareness of possible pitfalls when bringing a Medtech product to the market
  • Know where and how to find required information

Target Audience

  • Researcher in the field of translational medicine
  • Employees from spin-offs, startups, who want to bring a product to the market
  • Employees from companies who want to get an overview on regulatory affairs
  • Investors in medical devices who would like to understand risks and opportunities with the evolving regulatory framework in EU


  • Affinity to or involved in Medtech or Life Sciences
  • Basic understanding of Good Practices in product development and innovation
  • Technical / scientific background or commercial background linked to Life Sciences products