MTRC announces the start of the new service - Analysis of Tender Requirements for Medical Devices. Our team thoroughly reviews the criteria that procurement bodies use to evaluate bids. We break down how factors like price, quality, clinical and economic evidence, and sustainability influence decision-making. With these insights, we guide you in aligning your product’s unique strengths to the specific expectations of different European markets.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Value-Based Publications Digest. In a recent publication, Chu et al. conducted a systematic review to develop an admission criterion framework for high-cost medical consumables in governmental hospitals. The study was carried out in a multi-country context and established a framework with seven first-level and 23 second-level indicators, highlighting the primacy of “Clinical Benefit,” followed by “Economic Value,” and “Organizational Impact.” This framework helps decision-makers ensure both efficient resource allocation and robust clinical outcomes.

On February 18, 2025, the Swiss Health Observatory (Obsan) published its 2023 report confirming the ongoing shift from inpatient to outpatient care in Switzerland. The number of procedures required to be performed in outpatient settings to be reimbursed expanded from six in 2019 to 18 in 2023, with outpatient costs two to eight times lower. Despite the shift, overall healthcare costs have risen due to an increase in treatment volumes.

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, Cimprich et al. discussed strategies of regulatory actors, particularly market authorization agencies, health technology assessment agencies, and health care procurement agencies, for integrating environmental sustainability requirements into the regulation of medicines and medical devices. Their analysis, contextualized within diverse healthcare settings, reveals significant untapped possibilities for strengthening regulatory frameworks to mitigate the ecological footprint of health technologies.

On February 17, 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 200 and 096 with changes to be implemented no later than March 10, 2025. Thirty-five new procedure codes related to cardiovascular, gastrointestinal, nephrology, peripheral vascular, and general surgery areas and ten new diagnostic codes concerning in-vitro diagnostics, endoscopy, and pulmonology were introduced.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, van den Broek-Altenburg et al. reviewed 20–25 years of economic value assessment approaches in healthcare, highlighting the growing focus on individual preferences over broad societal metrics in value-based care models. The study underscores the complexities of incorporating patient-specific preferences into economic evaluations, and addresses recognized limitations of QALY measures. The authors discussed emerging alternative valuation frameworks that could influence future policy and reimbursement decision-making.

In February 2025, the Danish Health Data Authority opened the application period for changes to the 2027 DRG logic, including the creation of new DRG codes and modifications to the grouping logic for existing DRGs. The application deadline is October 31, 2025.

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 study, Puñal-Riobóo et al. developed a standardized minimum outcome dataset for left ventricular assist device (LVAD) registries to address key evidence gaps and meet the needs of Health Technology Assessment (HTA) bodies and healthcare professionals. Building on prior HTA findings from EUnetHTA, the authors conducted a structured three-round Delphi process with an expert panel of cardiologists to assess the relevance of various outcome measures. The consensus resulted in 18 key outcomes and 47 variables across seven healthcare domains, strengthening the reliability of real-world evidence and supporting more informed clinical and policy decisions.

The French National Authority for Health (HAS) has released new recommendations about add-on reimbursement of medical devices and medical aids from the February 2025 meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS). Sixteen favorable opinions were published concerning the registration or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). They relate to cardiovascular and peripheral vascular, neurovascular, endocrinology, interventional radiology, nephrology and urology, orthopedic devices, and medical aids.

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, Schweitzer et al. explored the suitability of the current German HTA dossier templates for the impending EU joint clinical assessment (JCA). The study examined how extensively safety endpoint and subgroup analyses in German dossiers were actually considered by IQWiG and the G-BA. The authors found that the current German HTA templates significantly increased the workload of HTA developers while leaving many reported outcomes unconsidered by IQWiG and G-BA. To mitigate duplicative efforts and ensure prompt availability of medicinal products in line with the EU HTA Regulation framework, the authors recommend well-defined dossier requirements, early consultations, and proactive engagement with HTA developers.

In late February 2025, the Innovation Committee at the Federal Joint Committee (G-BA) published the decision recommending the transfer to standard care for the completed project in the peripheral vascular field. The project was dedicated to the integration and spatial analysis of regional, site-specific, and patient-specific factors to improve the quality of care in carotid artery revascularization.

MTRC developed an analytical White Paper featuring the Health Economic Evidence Requirements for Medical Devices across the BIG5 European markets: England, France, Germany, Italy and Spain.