An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations-Reference-Cited by-同舟云学术

An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations

Published:2023-04-03 Issue:4 Volume:20 Page:259-271
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Tarricone Rosanna¹²^ORCID,Banks Helen²^ORCID,Ciani Oriana²³^ORCID,Brouwer Werner⁴^ORCID,Drummond Michael F⁵^ORCID,Leidl Reiner⁶^ORCID,Martelli Nicolas⁷^ORCID,Sampietro-Colom Laura⁸^ORCID,Taylor Rod S.⁹^ORCID

Affiliation:

1. Department of Social and Political Science, Bocconi University, Milano, Italy

2. SDA Bocconi School of Management, Centre for Research on Health and Social Care Management (CERGAS), Milano, taly

3. SDA Bocconi School of Management, Government, Health & Not-for-profit Division Health Economics & HTA, Milano, Italy

4. Erasmus University Rotterdam, Erasmus School of Health Policy & Management (ESHPM), Rotterdam, Netherlands

5. Centre for Health Economics, University of York, York, UK

6. Ludwig-Maximilians-Universitat Munchen, Munich School of Management, Munchen, Germany

7. Pharmacy Department, Assistance Publique - Hopitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France

8. Health Technology Assessment Unit, Hospital Clinic de Barcelona, Barcelona, Spain

9. University of Glasgow, Institute of Health and Wellbeing, Glasgow, United Kingdom of Great Britain and Northern Ireland

Funder

financially supported by the SDA Bocconi School of Management through an unrestricted grant provided by Edwards LifeScience

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2023.2192868

Reference89 articles.

1. Regulation (EU) 2017/745 of the European parliament and of the council of 5 April 2017 on medical devices, amending directive 2001/83/EC, regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) [Internet];European Union;OJ L,2017

2. European Union. Regulation (EU) 2021/2282 of the European parliament and of the council of 15 December 2021 on health technology assessment and amending directive 2011/24/EU (Text with EEA relevance) [Internet]. Dec 15 2021. Available from: http://data.europa.eu/eli/reg/2021/2282/oj/eng.

3. Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective;Tarricone R;Expert Rev Med Devices,2020

4. CHANGING HEALTH TECHNOLOGY ASSESSMENT PARADIGMS?;Husereau D;Int J Technol Assess Health Care,2016

5. Regulatory and HTA early dialogues in medical devices;Blankart CR;Health Policy,2021

Cited by 5 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Early access programs for medical devices in France: Overview of recent reforms and outcomes (2015-2022);Health Policy;2024-10

2. Domains and Methods of Medical Device Technology Evaluation: A Systematic Review;Public Health Reviews;2024-07-24

3. Health Technology Assessment: Current State of Access to Medical Device Outcomes;IFMBE Proceedings;2024

4. International Market Access Strategies for Artificial Intelligence–Based Medical Devices: Can We Standardize the Process to Faster Patient Access?;Mayo Clinic Proceedings: Digital Health;2023-09

5. European expert recommendations on clinical investigation and evaluation of high‐risk medical devices for children;Acta Paediatrica;2023-08-15