Health Technology Assessment Landscape for Medical Devices in Europe
Author(s)
Laure Weijers, PGCert1, Michelle Smith, MSc2.
1Senior Consultant, Lumanity, Utrecht, Netherlands, 2Lumanity, London, United Kingdom.
1Senior Consultant, Lumanity, Utrecht, Netherlands, 2Lumanity, London, United Kingdom.
OBJECTIVES: The Regulation on Health Technology Assessment 2021/2282 (HTAR) establishes a transparent, harmonized framework for cooperation among EU Member States (MS) in conducting Joint Clinical Assessments (JCAs). Health technology developers (HTDs) of Class IIb/III medical devices (MDs) and Class D in-vitro diagnostic MDs selected for JCA must prepare to meet the HTAR requirements to avoid delays and ensure patient access. We examined existing national HTA guidance for MDs across the 27 MS.
METHODS: In June 2025, HTA websites of the 27 MS were hand-searched to identify HTA guidance for MDs, using English-language keywords and local language translation. Information was reviewed, extracted and summarized. Features of interest included the assessment objective, guidance available, MDs assessed, level of detail in published reports, and key evidence themes.
RESULTS: Fourteen MS with HTA guidance for MDs were identified, either combined with medicinal products or as dedicated MD chapters. All countries with HTA guidance included an assessment of efficacy/safety; 11 also involved economic considerations. The level of detail varied substantially. Additionally, France, Italy, Poland and Sweden provided or referred to specific methodological guidance. For example, guidance in Sweden discusses evidence evaluation issues for diagnostics, and Italy refers to the principles of clinical evaluation and methodological approach in the Regulation (EU) 2017/745 (Medical Device Regulation). Public MD HTA guidance was not identified for 12 MS, where decision-making may be internalized within authorities and/or leaning on other countries’ reports.
CONCLUSIONS: While HTA systems for medical products are well-established, this is less so for MDs. The HTAR reflects a shift in the role of HTA for MDs, with significant potential to impact local decision-making. The HTAR offers MD HTDs opportunities to gain an early understanding of evidence requirements, which may be more stringent than before for MDs, and an opportunity for national HTA institutions to improve decision-making transparency.
METHODS: In June 2025, HTA websites of the 27 MS were hand-searched to identify HTA guidance for MDs, using English-language keywords and local language translation. Information was reviewed, extracted and summarized. Features of interest included the assessment objective, guidance available, MDs assessed, level of detail in published reports, and key evidence themes.
RESULTS: Fourteen MS with HTA guidance for MDs were identified, either combined with medicinal products or as dedicated MD chapters. All countries with HTA guidance included an assessment of efficacy/safety; 11 also involved economic considerations. The level of detail varied substantially. Additionally, France, Italy, Poland and Sweden provided or referred to specific methodological guidance. For example, guidance in Sweden discusses evidence evaluation issues for diagnostics, and Italy refers to the principles of clinical evaluation and methodological approach in the Regulation (EU) 2017/745 (Medical Device Regulation). Public MD HTA guidance was not identified for 12 MS, where decision-making may be internalized within authorities and/or leaning on other countries’ reports.
CONCLUSIONS: While HTA systems for medical products are well-established, this is less so for MDs. The HTAR reflects a shift in the role of HTA for MDs, with significant potential to impact local decision-making. The HTAR offers MD HTDs opportunities to gain an early understanding of evidence requirements, which may be more stringent than before for MDs, and an opportunity for national HTA institutions to improve decision-making transparency.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA174
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas