Digital Health in Luxembourg
Key Figures
660,000
residents
5%
of GDP allocated to the health sector in 2021
935,000
people enrolled in the social security system, one-third of whom are cross-border workers
136
MedTech companies based in Luxembourg
A commitment to quality and innovation to ensure an inclusive healthcare system
In Luxembourg, the Ministry of Health and the Ministry of Social Security are responsible for the healthcare system, which is based on values such as quality, equity, trust, and attractiveness.
The patient-centered healthcare system guarantees universal access to care, whether for residents or foreign workers through their employment contracts.
Luxembourg’s social security system:
It is funded by public contributions and is based on the principle of mandatory enrollment. The risks covered include illness, maternity, workplace accidents or occupational diseases, old age and disability, as well as long-term care insurance. The number of people enrolled in one of the national health insurance schemes corresponds to 141% of Luxembourg’s population, since more than one-third of workers are cross-border commuters.
State-funded health care accounts for 83% of total health care spending. The role of private insurance in Luxembourg is primarily supplementary, covering approximately 60% of the population.
The National Health Plan:
In 2023, Luxembourg published its National Health Plan (NHP) for the next 10 years. This strategy, based on WHO recommendations, outlines the guidelines the country intends to implement to improve its healthcare system. It includes, in particular, a section on digital health, which aims to increase investment to improve the interoperability of IT systems and promote access to and sharing of health data.
The identified priorities are as follows:
- Modernization and digitization of healthcare infrastructure;
- Improving digitization through the development of the Luxembourg National Data Service (LNDS) and the creation of a Health Data Hub for the effective use and sharing of health data;
- Placing cybersecurity at the heart of the development of digital health infrastructures and platforms;
- Support for MedTech companies to facilitate market access;
- Participation in international projects such as NCER-PD (a research initiative on the early diagnosis of Parkinson’s disease) or Clinnova (an initiative aimed at promoting AI-driven precision medicine), and contribution to European initiatives.
How can I enter the Luxembourg digital health market?
1. Register the digital medical device with the Department of Health
Before placing the device on the market, the manufacturer prepares the EU Declaration of Conformity, which certifies that the devices comply with the provisions of the applicable standards. Any medical device bearing the CE marking may be placed on the market and put into service.
Once established in Luxembourg and in order to place its device on the Luxembourg market, the manufacturer must register with the Health Directorate: meddevices@ms.etat.lu.
There are specific language requirements regarding the drafting of information to be provided to users and patients:
- Instructions for active implantable medical devices must be written in French or German.
- Instructions for medical devices and in vitro diagnostic medical devices must be written in French, German, or Luxembourgish.
- Information regarding devices intended exclusively for professional use must be written in French, German, Luxembourgish, or English.
More information on the requirements for placing a digital medical device on the market.
2. Review the regulations and distribution of digital medical devices
- The Marketing Authorization (MA) is issued by the Ministry of Health based on an opinion issued by a national committee of experts (Committee of Experts).
- Regulatory validation of applications and registration in the national drug database by the Division of Pharmacy and Medicines (DPM) of the Health Directorate.
- The transport, storage, and handling of medicinal products for human and veterinary use are subject to Good Distribution Practices (GDP), in accordance with the specifications for the products in question.
3. Obtain the certificate of free sale
The Certificate of Free Sale (CLV) certifies that a manufacturer's medical device complies with applicable legislation and may be marketed in the European Union (EU). Applications should be submitted to meddevices@ms.etat.lu.
4. Submit safety monitoring reports
All pharmacovigilance reports (MIR, FSCA, PSUR, periodic summary reports, and trend reports) should be sent to meddevices.vigilance@ms.etat.lu.
Government agencies and platforms
They ensure the smooth operation of the healthcare system and promote cooperation within it.
Support and Innovation Initiatives
They promote and support the development of the digital health sector.
Incubators
Designed for entrepreneurs and relevant to the healthcare and health technology sectors.
Training Courses
Universities and their research groups foster and support digital innovations in healthcare.
Research Organizations
Key partners for innovation in the healthcare and health technology sectors.
Useful Resources
In Luxembourg, eHealth is based on a structured national framework that integrates digital services, health data processing, and user rights. At the heart of this system, the Shared Care Record (DSP) centralizes information relevant to care management, making it easily accessible to authorized healthcare professionals. Managed by the Luxembourg eHealth Agency, this system relies on a secure portal and digital services, including the eHealth mobile app. Users can thus access their data, track its use, and better understand how personal data is processed in accordance with Luxembourg law. This model promotes regulated data sharing, which is essential to the quality and continuity of care.
To access these services, eSanté activation is a key step. It is easily completed via MyGuichet, allowing each user to activate eSanté and gain access to MyDSP. Once the account is active, users can view their DSP health records, manage authorizations with healthcare professionals, and use the features offered by the mobile app. MyDSP thus provides centralized access to health information, making it easier to use digital services on a daily basis. If users encounter difficulties accessing the platform or have questions about using the DSP, resources are available to assist them, notably through the eSanté Agency, which offers support tailored to different user profiles.
The management of personal data is a fundamental pillar of the eHealth system in Luxembourg. The processing of personal data—and in particular health data—is strictly regulated to ensure the protection of individuals with regard to data processing. The National Commission for Data Protection ensures compliance with regulations, particularly regarding data flow and the terms of service. Each user has rights over their data, including control over access to and use of that data. The principles of data protection are based on transparency, security, and the limitation of processing, ensuring controlled use of the DSP and strengthening trust in the entire Luxembourg eHealth system.
Within this structured environment, G_NIUS plays a key role in supporting stakeholders seeking to understand or enter the Luxembourg eHealth market. By providing a clear overview of existing services—such as the DSP healthcare record or the tools offered by the eHealth Agency—G_NIUS facilitates access to information and sheds light on issues related to data processing, user rights, and the structure of the sector. For project leaders, this understanding is essential for developing solutions that comply with national requirements, particularly regarding personal data and digital health services. Luxembourg thus offers a coherent framework where healthcare innovation, data protection, and quality of care converge, supporting the deployment of high-performance eHealth solutions tailored to the needs of both users and professionals.