German MedTech Insights: Deep Dive on Digital Health Applications & Medical Device Regulation

Jun 24, 2021 8:00AM


GACC Midwest – together with its partners Life Science Nord, Medical Valley EMN, NRW.Medizin and NRW Global Business – invites you to join two public sessions on the topic of MedTech in Germany on Thursday, June 24, 2021.

Key Takeaways

  • Learn about the Digital Healthcare Act and hear German case studies
  • Gain insights on MDR and how to enter Europe as an international company
  • Explore opportunities for transatlantic collaboration
  • Grow your German-American business network

Session 1: One Year of Digital Health Applications in Germany – A Perspective on the Market, Regulatory Framework and Best Practices 

Thursday, June 24, 2021 from 8:00am to 9:30am CT

This session will focus on digital health applications in Germany driven by the Digital Healthcare Act and other legislation ensuring better healthcare through digitization and innovation. Hear firsthand examples, case studies and best practices from both startups and established companies from Germany.

Agenda and speakers will be announced soon. Stay tuned!

Register for Session 1

About the Digital Healthcare Act

At the end of 2019, the German Bundestag passed the Act for Better Care through Digitization and Innovation called “Digital Healthcare Act”. In doing so, the legislature aims to advance digitization and innovation in the German healthcare system, make the healthcare system more efficient, and help ensure that data can be better used for research. Additionally, the German Federal Ministry of Health is extending the Innovation Fund until 2024 with €200 million per year to ensure quick implementation of new innovations and solutions in healthcare.

Session 2: MDR – Medical Devices in Germany and Europe 

Thursday, June 24, 2021 from 9:45am to 11:00am CT  

This session will give an overview of the EU Medical Device Regulation as well as insights on how to enter Europe as an international company.

Agenda and speakers will be announced soon. Stay tuned!

Register for Session 2

About the Medical Device Regulation (MDR)

The Medical Devices Regulation (EU) 2017/745 replaces the two EC Directives 93/42/EEC “Medical Devices” and 90/385/EEC “Active Implantable Medical Devices”. Changes and renewals to the Medical Device Regulation include medical device classification, requirements and evidence of safety and performance, technical documentation, clinical evaluation, post-market surveillance requirements, quality, and risk management as well as EUDAMED, UDI and labeling.

These virtual events are part of the Transatlantic Cluster Initiative which is supported by the Transatlantic Program of the Federal Republic of Germany, funded by the European Recovery Program (ERP) of the Federal Ministry for Economic Affairs and Energy (BMWi). This initiative offers a unique opportunity for the exchange of know-how, discussion of innovations and networking between clusters in the USA and Germany.