18.05.2021 - 19.05.2021 | Online | 09:15 am - 13:00 pm

Basics of Regulatory Affairs for Start-ups in Medical Technology 2021

A joint event from EIT Health Germany, Medidee and BadenCampus Online Seminar Series – Part I


In this first part of the seminar series “Market Access and Basics of Regulatory Affairs for Start-ups in Medical Technology” we will answer urgent questions surrounding the regulatory landscape in Medtech.  Regulatory know-how is necessary and offers advantages as early as the development stage and significantly secures your later success. Join this seminar to understand the importance of regulatory requirements for medical technology products, get familiar with the Medical Device Regulation (MDR) and learn how to navigate through the necessary steps until market entry.  All participants will receive a certificate of attendance.

The Event will take place online. Agenda and Registration can be found here. We recommend to attend both seminar days as the content was created based on a holistic approach.

Agenda Day 1 (Tuesday, 18.05.2021)

09:15: Welcome by the Organizers

09:20: Introduction – Steps to CE Mark for Medical Devices (Medidee)

  • MDR / IVDR
  • Medical device classification – conformity assessment
  • General safety and performance requirements (GSPR)
  • State of the art concept – principle of presumption of conformity
  • Role of Notified Bodies and working with Notified Bodies
  • Status update – implementation of MDR / IVDR

10:30: V&V and Technical Documentation (Medidee)

  • Risk management & usability engineering
  • Setting up a design & development process
  • From user requirements to design validation
  • Design verification and pre-clinical validation
  • Technical documentation as evidence for compliance

12:00: Open Q&A (all speakers) - End of Day 1

Joint Lunch Break (feel free to stay for a chat and exchange your thoughts)


Agenda Day 2 (Wednesday, 19.05.2021)

09:15: Welcome by the Organizers

09:20: Clinical Evidence (Medidee)

  • Clinical data, clinical evaluation and equivalence discussion
  • Post market surveillance & post market clinical follow-up

10:30: US Market Access for Medical Devices (Medidee)

  • Regulatory framework
  • Classification: 510(k), De Novo, HDE, PMA
  • FDA medical devices databases
  • Pre-submission programme
  • Differences between US and EU regulatory frameworks

11:40: Start-up and Regulatory – avoiding pitfalls (Medidee)

  • Milestones of a medical device innovation project, a different view

12:00: Open Q&A (all speakers), Closing, Outlook

Next Event

Stay tuned for Part II of the Series, “Market Access for MedTech-Start-ups”, that will take place on October 5-6.

Further informations


The event is free of charge


Please click here to register for this event

Further informations:

Basics of Regulatory Affairs for Start-ups in Medical Technology 2021


Lena Weller

+49 621 764 461-11