Le Gouvernement du Grand-Duché du Luxembourg
Fit 4 Innovation – HealthTech Market

Accelerate market access for your health technologies

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.
Certified consultant directory

Are you looking to align your medical devices with the applicable regulatory compliance process?

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, establish your regulatory roadmap, and, for the most advanced participants, identify accelerators and avoid dead ends in the regulatory processes. 

An experienced expert will help you define an action plan for your company and provide additional support to implement the recommendations.

Interested in joining Fit 4 Innovation – HealthTech Market? 

  • Contact us to express your interest. We will conduct a pre-analysis of your needs.
Ask for support

Key figures

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

The programme is open to Luxembourg small and medium-sized companies, with the intention to launch new and innovative medical devices on the European market. The programme is designed to cover the needs of all healthtech companies, in particular those developing digital technologies such as medical software, artificial intelligence or data security algorithms. 

In order to be eligible, you must: 

  • Be a small or medium-sized company based in Luxembourg
  • Not be considered as an “undertaking in difficulty”
  • have a valid business permit
  • not carry out an activity excluded from general SME aid schemes by the regulations


Join Fit 4 Innovation – HealthTech Market
    • Contact Luxinnovation to express your interest. We will conduct a pre-analysis of your needs.
    • Choose a certified consultant and ask for a quotation
    • Fill out the online application form. We will make sure your application is in line with the Fit 4 Innovation – Health Tech Market rules and provide you with a confirmation document.
    • Submit your application form to the Ministry of the Economy, attaching the confirmation document provided by Luxinnovation.
    • Validate the quotation from your consultant once the Ministry of the Economy has confirmed the reception of your application. 
    • Start you project together with the consultant:
      • Receive your personalised recommendations including an action plan with cost estimates reviewed by Luxinnovation.
      • Implement the consultant recommendations. Guidance from Luxinnovation to additional suitable aid measures from the Ministry of the Economy will be included (if relevant).
    • Request the payment of the public subsidy covering the consultancy costs for the analysis.
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Are you an experienced coach? 

If you have a confirmed track record in assessing and coaching companies in the field of medical device regulations, consider becoming a consultant. 

Read more

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