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

Four simple steps to implement an effective market watch

30-03-2023

Companies that want to stay ahead of the competition must be aware of important market developments and strategically position themselves vis-à-vis their competitors to take advantage of market opportunities using the information they have obtained. During a Club Innovation event, which was jointly organised by the Luxembourg Chamber of Trade, the Enterprise Europe Network - Luxembourg, and Luxinnovation on 14 March 2023, Market Intelligence Analysts at Luxinnovation, Paul-Louis Bene and Julie Gaspar, broke down the fundamentals of implementing an effective market watch into four key steps.
Read more

Creative Industries Cluster B2B Meet up: “Building trust is a priority”

28-03-2023

On 21 March 2023, the Luxembourg Creative Industries Cluster organised a B2B meetup to promote cross-sector synergies within the ecosystem. Around 40 people attended the event at the Blends Café in the heart of Luxembourg, including company representatives and creative entrepreneurs. The meetup, which coincided with World Poetry Day, was an excellent opportunity to introduce the new Cluster Manager, Kristian Horsburgh, and marked the cluster’s first gathering in 2023.
Read more

Luxembourg Digital Innovation Hub gets new European dimension

23-03-2023

The designation as European Digital Innovation Hub (E-DIH) broadens the scope of the Luxembourg Digital Innovation Hub (L-DIH) as a one-stop-shop for the digital transformation of the Luxembourg manufacturing sector by providing additional channels and financial resources for more impact in Luxembourg and Europe. With Luxinnovation, the national innovation agency, continuing its role as coordinator, four additional partners now join the L-DIH consortium to considerably extend its service offer.
Read more

New healthtech business developer joins Luxinnovation

22-03-2023

The international business development team at national innovation agency Luxinnovation informs and guides international companies considering Luxembourg as a potential location for their European offices. On 1 March 2023, Régis Ciré joined the team and took on the role of supporting healthtech businesses.
Read more

Latvia-Luxembourg wood sector forum participants accentuate collaborative research

16-03-2023

Luxinnovation co-organised a hybrid business forum for the wood sector during the just concluded official trade mission to Latvia with the aim to facilitate exchanges between the Luxembourg wood companies and representatives from the Latvian wood sector. During the meeting, both parties expressed their interest in expanding economic cooperation and developing joint research activities.
Read more

All news

Close