EU HTA PICO Framework for Medical Devices

MTRC provides Early PICO Planning services to support a smooth and effective Joint Clinical Assessment (JCA) process under the new EU Health Technology Assessment (HTA) Regulation for innovative medical devices.

With the enforcement of the EU HTA Regulation, medical device manufacturers face intensified requirements to demonstrate clinical value for market access, HTA endorsement, and reimbursement across the European Union. The Joint Clinical Assessment (JCA) will be a pivotal step in this process.

A key component of the JCA is scoping, which uses the PICO (Population, Intervention, Comparator, Outcomes) framework to define the specific parameters of an HTA review:

Population: The patient demographic or clinical setting for which the device is intended
Intervention: The medical device or procedure being evaluated
Comparator: The current standard of care or alternative solutions
Outcomes: Clinical, patient-centric, or economic measures assessing effectiveness and safety

One challenge of the JCA PICO process is that each EU member state can submit inputs, potentially leading to numerous final PICOs. This complexity means manufacturers must address all suggested populations, comparators, and outcomes in a very short time, reserved for development of the HTA application. Member-state-driven variability and tight timelines can be a major hurdle for successful preparation.

MTRC’s unique expertise in EU Med Tech market access, HTA, and PICO-driven planning helps you navigate these challenges with confidence, ensuring a stronger market position for your medical technologies.

Early PICO Planning Process

At MTRC, we guide you through each stage of HTA preparation with a focus on creating an optimized PICO framework for your medical device.

Analyze the Current Diagnostic and Treatment Landscape in All Member States

We analyze clinical guidelines by clinical societies and governmental organizations (e.g. HAS in France and National Board of Health and Welfare in Sweden), audits and patient registries as well as published surveys of physicians or medical chart reviews to understand current patient pathways in all member states.

Determine the Position of Reimbursement and HTA Authorities

We evaluate perspectives from reimbursement and HTA organizations by examining previously published HTA reports, reimbursement decisions, and other relevant documents. This helps us identify member-state-specific patient populations, preferred comparators (reflecting the standard of care), and outcomes, all of which may vary significantly by country.

Consolidate PICOs for All Member States

Utilizing analysis of current clinical practice, previous reimbursement and HTA decisions, we develop a comprehensive list of potential PICOs. This consolidated framework reflects variations in practice and payer expectations across EU member states.

Develop Strategic Recommendations for Evidence Generation

We conclude the process by providing a strategic gap analysis and recommending next steps for evidence generation, ensuring you are well-prepared for a successful JCA submission.

Why partner with MTRC?

Be confident in the results

We are accredited by the United Kingdom Accreditation Service (UKAS) as an ISO 9001:2015 certified vendor, specialised in medical technologies market access. Unlike many of our competitors, we dedicate 100% of our time and focus to the area of medical technologies, so that our clients enjoy higher quality services at a lower cost. We are also probably the largest Med Tech market access consultancy in Europe, which helps us accumulate unique knowledge and insight

Leverage unique Pan-European expertise

MTRC covers 20 European countries, including Austria, Belgium, Czech Republic, Denmark, England, Finland, France, Germany, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, and Switzerland. Our unparalleled breadth uniquely positions us to address the diverse requirements of multiple EU member states in the JCA preparation process.

Spend less on consulting

We understand the budgetary challenges of the med tech industry and can therefore offer a cost-effective approach to our specialised services. Twelve (12%) of our current business comes from small to medium-sized enterprises (SMEs) – a testament to our unique and personal approach to solve your budgetary challenges

Make decisions and advance your business quickly

We appreciate the time-sensitive nature of market access. Being a flexible team, we are not afraid to go beyond regular working hours to meet the high expectations of our clients. For every type of project, we offer the shortest possible turnaround times

News and insights

17 Mar 2025

EU HTA Publication Digest: Managing experts' conflicts of interest in the EU Joint Clinical Assessment

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, Gentilini et al. critically examined the European Commission’s 2024 Implementing Regulation on conflict-of-interest management in the EU Joint Clinical Assessment (JCA). A review of national HTA policies showed that the new conflict-of-interest management approach is largely modeled after French HTA guidelines. The authors identified concerns related to expert representativeness, disclosure clarity, and enforcement challenges. These findings highlighted the need for greater transparency and resource allocation to ensure an impartial assessment process.

10 Mar 2025

EU HTA Publication Digest: Advancing cooperation in Health Technology Assessment in Europe: insights from the EUnetHTA 21 project amidst the evolving legal landscape of European HTA

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, Urbina et al. analyzed the EUnetHTA 21 project, a European initiative designed to support the implementation of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA). Conducted by 13 European HTA bodies, the project resulted in 20 guidance documents, 13 templates, and pilot Joint Clinical Assessments (JCAs) aimed at refining evaluation methods. The study highlights the importance of structured collaboration and regulatory preparedness, providing a roadmap for the future integration of HTA at the EU level.

03 Mar 2025

EU HTA Publication Digest: Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose

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.

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