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

How to apply for services?

• Check your eligibility:
  • Does your company meets the SME definition of the EU (more details via SME self-assessment)?
  • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
  • Before you apply, read the full Online Seminar Description
  • Complete application form
  • Submit your application and your de minimis self-declaration to WestBIC codex4smes@westbic.ie by March 13, 2023 until 12:00 noon CET.