EIT Health: Medical Device Regulation Seminar

Innovators developing medical devices need to understand new European regulations governing their work. This seminar gives the legal and technical background on the rules that are now in effect.

The MDR seminar familiarises medical technology entrepreneurs and innovators with the new European Medical Device Regulation (MDR), and explains how it impacts the approval process. This certificate course offers a combination of knowledge acquisition in a University setting and the character of a seminar.

It provides the opportunity to make contacts with participants, who will be future specialists. Healthcare and industry professionals, entrepreneurs, medtech researchers, and students will be targeted for participation, and will be eligible to receive ECTS or CME credits for 10 different seminar days. Topics covered will include MDR fundamentals, country-specific reimbursement, risk management, clinical evidence, software for medical devices, eHealth, usability, post-market surveillance and the General Data Protection Regulation.

There are date options for most parts of the course:

• Introduction to the Medical Device Law (obligatory): 27 May 2020 & 03 June 2020
• Risk Management in Medical Engineering (obligatory): 10 June 2020 & 17 June 2020
• Webinar: 24 June 2020
• Other countries, other customs: USA, China, Brazil, Japan, Canada, Australia: 01 July 2020 & 08 July 2020
• Medical Device Regulation (MDR): 15 July 2020 & 22 July 2020
• Digital Health: 29 July 2020 & 05 August 2020

Register for the course