Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization Across 55 Jurisdictions

Speaker(s)

Malandrini FB1, Callea G1, Tarricone R2, Kerstan M3, Sampietro-Colom L4, Valledor A5, Balsamo A6, Catania D6, Vainieri S6, Tocchi M7, Tangila Kayembe O8, Melvin T9, Poulsson A10, Kuhn S11, Rappagliosi A12, Auclair P13, Gielkens M14, Santin C15, Roijers R16, Kvistgaard Jensen L17
1SDA Bocconi School of Management, Milano, MI, Italy, 2Department of Social and Political Science, Bocconi University, Milano, Italy, 3Johnson and Johnson Medical Devices, Zuchwil, Switzerland, 4Clinic Barcelona University Hospital, SABADELL, B, Spain, 5FCRB-IDIBAPS, Barcelona, B, Spain, 6HTA Unit, National Agency for Regional Health Services (AGENAS), Rome, Rome, Italy, 7Meditrial, New York, NY, USA, 8Assistance Publique - Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Pharmacy Department, Paris, Paris, France, 9Trinity College Dublin, Dublin, Leinster, Ireland, 10Norwegian Institute of Public Health, Oslo, Oslo, Norway, 11Institute for Digital Medicine University Medical Center & Philipps-University, Marburg, Germany, 12Edwards Lifesciences, Nyon, VD, Switzerland, 13Abbott, Brussels, Brussels, Belgium, 14Medtronic, Maastricht, Maastricht, Netherlands, 15W.L. Gore & Associates, Pordenone, Pordenone, Italy, 16Philips, Eindhoven, Eindhoven, Netherlands, 17Odense University Hospital, Odense, Odense, Denmark

Presentation Documents

OBJECTIVES: The objective of Pre-Market Approval Pathways (PMAP) for medical devices (MDs) is to guarantee MD safety and efficacy through generation of robust clinical evidence. As part of the Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) project funded by IHI, this study aims to identify the key PMAP features that sponsors must consider when applying for pre-market clinical investigation approval in different jurisdictions.

METHODS: A comprehensive database (DB) on PMAP was developed through systematic review of public sources. Data collected includes information on national legislation, procedures and rules (required documentation, timelines, language of submission, fees, reimbursement of investigational devices), existence of performance monitoring system, stakeholder involvement. PMAP-DB covers 55 countries (27EU+3EEA+25non-EU). A comparative analysis of approval pathways was conducted.

RESULTS: Data collection revealed high availability of information: national reference legislation was found in 53 countries (96.4%) and links to designed competent authority websites were universally available (100.0%). Submission procedures range from 1 to 6 across jurisdictions depending on class risk and other MD characteristics. Approval pathways are heterogeneous in terms of modes of sponsor-competent authority interaction, requirements, testing, documents, approval times and submission fees. The submission (of all or some documents) is permitted in English in almost all countries. Public databases for pre-market clinical investigations were found in only 17 countries (30.9%), performance monitoring systems in 5 (9.1%). Reimbursement of investigational devices is allowed in only 2 jurisdictions (3.6%). Stakeholder involvement (HTA bodies, patients, expert panels) in the design of pre-market clinical investigations was reported in only one country.

CONCLUSIONS: The significant variability in PMAP features across jurisdictions highlights the need for urgent harmonization to streamline global market access for medical devices. Improved alignment and standardization of approval pathways will facilitate more efficient and consistent regulatory processes, benefiting both sponsors and patients worldwide.

Code

HPR67

Topic

Health Policy & Regulatory, Medical Technologies, Organizational Practices

Topic Subcategory

Approval & Labeling, Coverage with Evidence Development & Adaptive Pathways, Medical Devices

Disease

Medical Devices