Multi-market entry | FDA and EU requirements for clinical investigations of medical devices

Online Workshop

23 March 2023 - 23 March 2023

Time: 14:00 - 16:30 CET (Amsterdam, Berlin, Paris)

For manufacturers of medical devices, it is strategically advantageous to consider the regulatory and market access requirements of different systems, such as in the EU or the USA, at the beginning of the development of new products in order to save costs. In addition, there are different requirements within the EU at the level of the member states.

In the first part of the workshop, small and medium-sized companies from the diagnostics industry will learn about the differences between the regulatory requirements of the US and EU systems when it comes to clinical testing of medical devices, such as diagnostics. Amko Groeneveld (novineon CRO GmbH) will provide step-by-step guidance through the requirements for generating clinical data, identifying and navigating FDA sources, and using available information.

At the EU level, there are also a number of good reasons for manufacturers of digital health solutions why entering the market in different ones can be advantageous. As an example, the Netherlands and Sweden are presented by Björn Ursing (PhD Senior Project Manager Life Science & Health, Embassy of the Kingdom of the Netherlands) in the second part of the workshop. Both countries have a high level of digital readiness in healthcare and have a good market size (read more). In addition, the procurement systems of the two countries differ. In Sweden, regions are responsible for procurement and use public tenders, while in the Netherlands, hospitals and insurers procure directly. Dual market entry allows companies to test their business models in two compatible but different markets.

The workshop is limited to three SMEs and is divided into two sessions. In the first session, the three SMEs will receive a two-hour introduction to multi-market entry of medical devices. In the second session, a 1:1 meeting (up to 30 minutes) can be arranged directly after the workshop if participants wish to ask confidential questions. A confidentiality agreement can be exchanged before each 1:1 conversation.


This workshop will include:

  • System Comparison - What are the differences for marketing applications in the US and conformity evaluations in the EU?
  • How to navigate FDA resources for identification of special controls, endpoints and extend of clinical investigations, illustrated using examples
  • Identification of specific items requiring clinical data for conformity evaluation in the EU, illustrated using examples
  • Consolidation and provision of a step-by-step approach for gathering FDA and EU requirements for clinical investigations of medical devices





Part I

System Comparison - Differences for marketing applications in the US and conformity evaluations in the EU

Amko Groeneveld, Consultant, novineon CRO GmbH


5 minutes

  • Rising regulatory requirements for generating clinical data
  • Workshop outline and goal

System comparison

5 minutes

  • Key aspects of the US- and EU-market for medical devices
  • Medical device classification
  • Device submissions in the US – logic/approach
  • Conformity evaluation in the EU – logic/approach


30 minutes

Navigation of FDA resources using example devices for a 510(k) submission and a PMA submission

  • How can available information be used to shape a clinical investigation/animal trial?
  • Considerations for De Novo devices

FDA – recap

10 minutes

  • Specific questions regarding the identified FDA resources, their navigation and use of the available information can be addressed here


30 minutes

  • Specific items requiring support from clinical data are identified, “to dos” for manufacturers are provided and an example per item is used for illustration

EU – recap

10 minutes

  • Specific questions regarding items requiring support from clinical data can be addressed here


30 minutes

  • Based on the previous sections, a step-by-step approach is discussed for identification of aspects eligible for clinical testing to meet requirements of the US- and EU-market. Note that this cannot be an all-inclusive recipe but may serve as guidance.

Part II

#dualmarketentry - a dual first market for digital health

Speaker: Björn Ursing, Embassy of the Kingdom of The Netherlands in Stockholm

Market entry in the Netherlands & Sweden

 30 minutes

  • New business development strategy with MDR
  • Good and bad
  • Start market access early – more at stake when doing trials under MDR

How to apply for services?

Note: The online training is limited to three SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.

Note: Our services are in general open to SMEs from all over North-West Europe with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered.

More information: The online coaching is part of the Interreg NWE-funded Codex4SMEs project. Since 2017, Codex4SMEs has built a large European network in the field of diagnostics and personalized medicine. More than 300 small and medium-sized enterprises have so far benefited from the opportunities offered. These include various events and tailored services that support SMEs in the development of innovative diagnostics.

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