Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation-Reference-Cited by-同舟云学术

Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new European regulation

Published:2022-08-03 Issue:8 Volume:19 Page:613-621
ISSN:1743-4440
Container-title:Expert Review of Medical Devices
language:en
Short-container-title:Expert Review of Medical Devices

Author:

Garzotto Francesco¹²³^ORCID,Comoretto Rosanna Irene¹⁴^ORCID,Dorigo Lorenzo³^ORCID,Gregori Dario¹^ORCID,Zotti Alessandro⁵^ORCID,Meneghesso Gaudenzio⁶^ORCID,Gerosa Gino⁷^ORCID,Bonin Mauro⁸

Affiliation:

1. Department of Cardiac Thoracic Vascular Sciences and Public Health, Unit of Biostatistics, Epidemiology and Public Health, University of Padua, Padua, Italy

2. Healthcare, ASL VCO, Verbania, Italy

3. Healthcare - Veneto Region, Azienda Zero, Padua, Italy

4. Department of Public Health and Pediatrics, University of Turin, Turin, Italy

5. Department of Animal Medicine, Production and Health, University of Padua, Legnaro, Italy

6. Department of Information Engineering, University of Padova, Padova, Italy

7. Cardiac Surgery Unit, Department of Cardiac, Thoracic, Vascular Sciences and Public HealthUniversity of Padua, Padua, Italy

8. Department of Health Instrumental Resources, Veneto Region, Venice, Italy

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine,Surgery

Link

https://www.tandfonline.com/doi/pdf/10.1080/17434440.2022.2118046

Reference55 articles.

1. Medtech-Europe. The European medical technology industry in figures 2021. [Internet]. [cited 2022 Jul 14]. Available from: https://www.medtecheurope.org/wp-content/uploads/2021/06/medtech-europe-facts-and-figures-2021.pdf.

2. 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. 175.

3. Europeans are left to their own devices

4. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices

5. Can it work? Does it work? Is it worth it?

Cited by 7 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. The value of using real-world evidence as a source of clinical evidence in the European medical device regulations: a mixed methods study;Expert Review of Medical Devices;2023-12-05

2. Mapping the development process of transcutaneous neuromuscular electrical stimulation devices for neurorehabilitation, the associated barriers and facilitators, and its applicability to acquired dysarthria: a qualitative study of manufacturers’ perspectives;Disability and Rehabilitation: Assistive Technology;2023-10-19

3. Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium;European Heart Journal;2023-08-28

4. The New European Medical Device Regulation: Balancing Innovation and Patient Safety;Annals of Internal Medicine;2023-06

5. The medical device regulation (MDR) from a dental perspective;Frontiers in Dental Medicine;2023-03-23