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

14 Apr 2025

EU HTA Publication Digest: Implementation of the EU's Health Technology Assessment regulation: where does existing methods guidance require concretization and what are the relevant methodological options?

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, Goetz et al. examined where EUnetHTA guidance documents require further methodological clarity in light of the upcoming EU HTA regulation. Through a systematic document review and structured stakeholder discussions conducted in Austria, the authors identified 32 key areas in need of refinement ‒ primarily related to evidence synthesis and eligibility criteria. Drawing on established HTA and evidence synthesis handbooks, the authors proposed concrete methodological options, offering actionable insights to support implementation across EU member states.

07 Apr 2025

EU HTA Publication Digest: The EU Health Technology Assessment Regulation Halo Effect: Are Cross-Functional Teams Ready?

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, Tanner et al. examined key cross-functional challenges stemming from Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) and how manufacturers should address them in their EU HTAR readiness plans. Conducted through literature review, guidance analysis, and manufacturer insights, the study identified five key cross-functional areas: global asset strategy, non-EU regional readiness, launch sequence evolution, brand perception, and pricing impacts. Given the central role of market access in bringing innovation to patients, the EU HTAR will have far-reaching implications, with early Joint Clinical Assessment reports expected to significantly influence brand strategy, pricing dynamics, and global launch sequencing.

31 Mar 2025

EU HTA Publication Digest: What is needed to successfully implement the EU HTA Regulation enabling broad patient access in Europe

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, Lipska et al. explored the policy challenges surrounding the implementation of the EU HTA Regulation, drawing from the discussions of a high-level expert group convened in Rome. The authors proposed actionable recommendations to facilitate the effective launch of the Joint Clinical Assessment framework. Their key insights stress the need for transparent communication, stakeholder engagement, and equitable commitment from all member states to reduce access delays across Europe.

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