On March 19, 2025, the Ministry of Labor, Health, Solidarity and Families published the Decree establishing a regulatory framework for the restoration and traceability of medical devices for individual use. It mandates that only certified centers may perform refurbishment, introduces a national registry for tracking restored devices, and links LPPR reimbursement to compliance with restorability criteria (pending further specification of applicable device categories).

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Al Sayah et al. conducted a systematic literature review to summarize and evaluate minimally important difference (MID) estimates for EQ-5D instruments. The review included 90 studies reporting 840 MID estimates and revealed a wide variability in MID values depending on the population, estimation method, and EQ-5D version. The findings emphasize the need for context-specific MID selection when interpreting EQ-5D outcomes.

MTRC, a leading boutique Med Tech market access consultancy in Europe, is looking for a Senior Market Access Consultant.

MTRC, a leading boutique Med Tech market access consultancy in Europe, is looking for a Senior Health Economist.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Sarri et al. investigated the methodological alignment between EU joint clinical assessments and national HTA requirements in France, Germany, The Netherlands, and Spain. While the study found strong consensus on the need for systematic evidence generation, national agencies diverged in their guidance on evidence derived from indirect treatment comparisons. These findings highlight the challenges health technology developers face in meeting both EU-wide and local evidentiary demands.

On April 10, 2025, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 201 and 097 with changes to be implemented no later than June 11, 2025. Ten new procedure codes concerning men’s health, endoscopy, gynecology, orthopedic, and surgical procedures fields and seven new diagnostic codes were introduced.

In April 2025, the Dutch Organization for Health Research and Development (ZonMw) opened the submission of grant applications for subsidy rounds for two Med Tech-related programs: the Innovative Medical Devices Initiative (IMDI) program and the Care Evaluation and Appropriate Use program.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Garin et al. developed a framework to promote sustainable inhaler prescriptions in Spain. The authors created a national database and decision-making algorithm to integrate environmental impact into clinical decision-making processes. Their analysis found that targeted shifts from high-emission pressurized metered-dose inhalers to dry powder inhalers could yield substantial environmental benefits. The study offers actionable insights for aligning respiratory treatment practice with environmental sustainability.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Weimar et al. developed a taxonomy and identified six archetypes of business models used by digital health technologies (DHTs) in the European Union. Drawing from 169 real-world DHT cases and 13 expert interviews, the study categorized models as: (1) administration and communication supporter, (2) insurer-to-consumer digital therapeutics and care, (3) diagnostic and treatment enabler, (4) professional monitoring platforms, (5) clinical research and solution accelerators, and (6) direct-to-consumer wellness and lifestyle. The authors identified three key innovation drivers in the DHT commercialization landscape: the direct targeting of patients and private individuals, the use of artificial intelligence as an enabler, and the development of DHT-specific reimbursement pathways.

On April 1, 2025, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) published its report on the utilization and development of digital health applications (DiGA) covering the period from September 1, 2020, to December 31, 2024. The report presents GKV’s key findings along with recommendations aimed at optimizing the current framework for DiGA reimbursement and regulation.

On April 9, 2025, the Ministry of Labor, Health, Solidarity and Families published the Order setting DRG tariffs and tariffs for other packages and supplements for 2025. New tariffs are applicable from March 1, 2025.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients to understand the potential scope of our support better. From the week of the 21st of April, we plan to work on 19 projects. Review the complete list of planned activities in this post.