The European regulatory framework for medical devices is currently in transition, making it necessary for healthtech companies to adapt to stronger requirements. In addition, in line with national priorities outlined in the Data-Driven Innovation Strategy, the Luxembourg healthtech sector is currently specialising in digital health. These digital health companies are thus facing strong challenges to ensure compliance with standards, dealing with an evolving regulatory landscape and a shortage of regulatory experts in digital health technologies.
The Fit 4 Innovation – Health Tech Market is a new initiative supported by the Luxembourg Ministry of the Economy and managed by Luxinnovation that aims to support healthtech start-ups and SMEs to overcome these difficulties and help them meet regulatory formalities required to obtain CE marking. The programme has specifically been designed to build up regulatory expertise in Luxembourg and facilitate access to this knowledge for Luxembourg’s healthtech companies, in particular in the field of digital technologies.
“We are very pleased to announce the launch of the Fit 4 Innovation – Health Tech Market programme for companies. 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.
11 consultancy firms, over 50 consultants
The programme draws on the expertise of external consultants and aims to support Luxembourg SMEs in the healthtech sector to navigate through the new European regulatory framework for digital medical devices.
Luxinnovation, with the input from the Ministry of Health, conducted an in-depth evaluation of external consultants and selected eleven consultancy firms covering a wide range of expertise to assist companies to comply with European regulations for medical devices and in vitro diagnostic medical devices.
“We are particularly proud of the enthusiasm generated by the first call for consultants for the programme, and happy to officially announce the enrolment of eleven consultancy firms, with a very broad range of expertise covered by more than fifty consultants in total. Companies interested in the programme can now select their consultants among the list of enrolled experts,” says Ms. Meunier.
The Fit 4 Innovation – Health Tech Market programme primarily targets companies with little or no knowledge about medical regulations and require external guidance on the applicable standards.
Applications open from 1 March 2023
Starting 1 March 2023, Luxembourg-based SMEs and start-ups can apply to the programme at any time and request financial support from the Ministry of the Economy, covering up to 50% of the eligible fees of the consultant mission.
Following the selection of a consultant, an application can then be initiated using the online form on the Fit 4 Innovation – Health Tech Market programme page. A pre-analysis certificate, confirming the eligibility of the company and the alignment of the project with the programme scope, is then issued by Luxinnovation. This certificate is to be attached to a full application and request for state aid via MyGuichet.lu.
“The Fit 4 Innovation – Health Tech Market programme primarily targets companies with little or no knowledge about medical devices regulation and require external guidance on the applicable standards. This new tool is a very attractive opportunity, helping them to define and implement their roadmap towards the CE marking, thus accelerating the commercialisation of their medical products or services,” adds Ms. Meunier.
Photo credit: Piron Guillaume, Unsplash