search

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

Anne Meunier, Luxinnovation, explains the second Joint Call HealthTechThe 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

Read more

Luxembourg wood value chain (1/3): A growing ecosystem

29-11-2023

The new Luxembourg wood ecosystem mapping by Luxinnovation shows an increase in the number of companies. It also reveals that almost 20% of wood businesses were incorporated in the last four years.
Read more

A gateway to Europe from Japan

28-11-2023

A delegation made up of nine innovative Japanese companies is currently visiting Luxembourg from 27 to 29 November 2023, hosted by Luxinnovation and the House of Entrepreneurship. Their objective is to find out how they could benefit from Luxembourg as a gateway to Europe and find partners who could help them expand their business to the European market.
Read more

Data sharing: Bridges built between Luxembourg and Japan

27-11-2023

As one of Luxembourg’s early strategic GAIA-X project, the national GAIA-X coordinator paid a visit to his Japanese counterpart. This visit could lead to a much closer collaboration between Luxembourg and Japan.
Read more

Innovation Fund call for projects significantly reducing carbon emissions open

27-11-2023

The European Union’s Innovation Fund is a cornerstone in the EU’s commitment to combat climate change while promoting groundbreaking solutions in decarbonising industry. The deadline for the open call for projects is 9 April 2024, while the auction for renewable hydrogen project closes on 8 February 2024. The Luxinnovation team is available to inform and support applicants.
Read more

Horizon Europe: On the road to maturity and visibility

22-11-2023

The Horizon Europe Day event organised by Luxinnovation on 7 December 2023 will provide insights into securing funding for research and innovation projects or leveraging engagement in European-scale programmes.
Read more

All news

Close