1 Hour Free Consultancy - Germany

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Since May 2021, the new EU Medical Devices Regulation ((EU) 2017/745 Regulation on medical devices (MDR)) has come into force, and since May 2022, the new EU In-vitro Diagnostics Regulation ((EU) 2017/746 Regulation on in-vitro diagnostic medical devices (IVDR)) has followed.

This will be accompanied by far-reaching changes, including in the classification, clinical testing and quality management of medical devices and in vitro diagnostics.

Together with our partners, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.

Are all appointment options already taken? Please contact us at the following e-mail address to arrange additional appointments and options: moritz.hoyer@medidee.com

Benefit from a one-hour personal exchange with experts on topics such as:

  • Assessment of your regulatory positioning/strategy
  • Evaluation of the impact of new European regulations (MDR & IVDR) on your strategy
  • New product classifications and their impact (medical software, IVD, etc.)
  • Clinical evaluation according to MEDDEV 2.7/1 rev 4 and MDR/IVDR
  • Clinical investigation and clinical performance study
  • PMS and PSUR (Post Market Surveillance and Periodic Safety Update Report)
  • Quality management system requirements from ISO 13485: 2016.
  • Challenges in process validation of manufacturing processes
  • Supply chain management (MAIDS: Manufacturer, Authorized representative, Importer, Distributor, Suppliers)
  • Other questions you may have on Regulatory, Clinical and Quality Systems related to conformity assessment, CE marking or FDA market approval for medical devices.
  • Individual consultation