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Fit 4 Innovation – Health Tech Market helps companies define their regulatory roadmap to obtain CE marking for their new and innovative medical devices and thus accelerate their launch on the European market.

Do you want to better understand the complex regulatory compliance process that applies to your medical devices?

Obtaining CE marking is mandatory for introducing medical devices on the European market. For many companies, the process is fraught with uncertainty: Is my software considered as a medical device? Do I need to carry out a clinical study? What are the data protection and cybersecurity requirements? What documentation should I prepare? And so on. This programme helps you understand the specific characteristics of your product and establish your regulatory roadmap.

Key figures

  • 8 weeks analysis of your project/product and identification of the impact of medical regulations
  • 1 action plan with recommendations to comply with European regulations
  • Up to 12 months of support to implement the recommendations
  • Up to 50% of co-funding

Key benefits

Companies that are looking to increase their knowledge and understanding of the European regulatory framework for medical devices can benefit from this programme.

  • In-depth assessment of your company’s project/product and of the impact of medical regulations
  • Personalised recommendations with cost estimates
  • Advice from experienced, neutral experts approved by Luxinnovation
  • Financial support from the Ministry of the Economy
  • Guidance for the implementation of recommendations

Who can benefit from Fit 4 Innovation – Health Tech Market?

The programme is open to Luxembourg small and medium-sized enterprises (SMEs), with the intention to launch new and innovative medical devices on the European market.

The programme is designed to cover the needs of all health tech companies, in particular those developing digital technologies such as medical software, artificial intelligence or data security algorithms.

In order to be eligible, companies must:

  • be classified as SMEs according to the criteria of the European Union
  • be based in Luxembourg
  • not be classified as an “undertaking in difficulty”
  • have a valid business permit
  • not carry out an activity excluded from general SME aid by the regulations

Join Fit 4 Innovation – Health Tech Market

We are currently evaluating consultants. The programme will soon be open for companies.
Become a Fit 4 Innovation – Health Tech Market consultant
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