Goodwin Burri, Kelly; Spörri, Adrian (2020). The value of registry data in the clinical evaluation of medical devices. Medical writing, 29(2), pp. 16-21. European Medical Writers Association
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Goodwin Burri MedicalWriting 2020.pdf - Published Version Available under License BORIS Standard License. Download (519kB) | Preview |
Medical device manufacturers must continuously evaluate all clinical data available for their products marketed in Europe. With the European Medical Device Regulation 2017/745 coming into force in May 2021, manufacturers are required to assess available implant registry data as part of the clinical evaluation process. This new requirement will necessitate a closer collaboration between industry and registries to evaluate the safety and performance of high-risk devices. Medical writers should be aware of existing implant registries, understand what characteristics make a registry suitable to support regulatory requirements, and recognise both the value and the limitations of registries as a source of clinical evidence.
Item Type: |
Journal Article (Further Contribution) |
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Division/Institute: |
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM) |
UniBE Contributor: |
Spörri, Adrian |
Subjects: |
600 Technology > 610 Medicine & health 300 Social sciences, sociology & anthropology > 360 Social problems & social services |
ISSN: |
2047-4806 |
Publisher: |
European Medical Writers Association |
Language: |
English |
Submitter: |
Beatrice Minder Wyssmann |
Date Deposited: |
06 Aug 2020 12:49 |
Last Modified: |
05 Dec 2022 15:39 |
Related URLs: |
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BORIS DOI: |
10.7892/boris.145615 |
URI: |
https://boris.unibe.ch/id/eprint/145615 |
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