Starting 1 March, healthtechs can apply to the Fit 4 Innovation – Health Tech Market to get support from experts and ensure that their digital medical devices meet the newest European regulations.
Many healthtechs, especially startups and SMEs, struggle with deciphering the ever-changing EU regulations. As such they don’t always know whether the regulations consider their product a medical device or not, whether they need to carry out a clinical study or what documentation they need to prepare.
To help them answer all these questions and support them in obtaining their CE marking – without which they cannot launch their products – the Fit 4 Innovation – Health Tech Market was launched by Luxinnovation and the ministry of economy.
“The beauty of the programme is that it gathers around our national companies the most relevant international experts in the field potentially combined with state aid support,” explains Anne Meunier, Senior Advisor – HealthTech at Luxinnovation.
Together with the ministry of health, Luxinnovation has selected 11 consultancy firms that cover a wide range of expertise and are able to support healthtechs in meeting the newest EU regulations. They will not only support local companies in getting their products ready for the European market but they will also help build much-needed regulatory expertise in Luxembourg.
Following the acceptance of their application, companies will first have their product analysed for 8 weeks after which an action plan will be drafted which will help them comply with all the necessary regulations. Next to receiving up to 12 months of support to implement their action plan, the ministry of economy will also cover up to 50% of their consultancy fees.
To be eligible for the programme, 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.
To apply to the programme and learn more about the benefits, see here. Applications are open from 1 March 2023.
