| Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices. | |
| | |
MedLine Citation:
|
PMID: 22128518 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
|
The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA. |
| | |
Authors:
|
Imgard Vinck; Frank Hulstaert; Hans Van Brabandt; Mattias Neyt; Sabine Stordeur |
Related Documents
:
|
3003408 - Transmission of measles in medical settings. 1980 through 1984. 8609848 - Teaching hospital medical staff to handwash. 2922688 - Reporting peer review actions to the texas state board of medical examiners. 16617948 - Sbar: a shared mental model for improving communication between clinicians. 17290728 - Free internal medicine case-based education through the world wide web: how, where, and... 18999178 - Use of decision support to prevent errors when documenting height and weight in the hos... |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: European journal of health law Volume: 18 ISSN: 0929-0273 ISO Abbreviation: Eur J Health Law Publication Date: 2011 Dec |
Date Detail:
|
Created Date: 2011-12-01 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 9431861 Medline TA: Eur J Health Law Country: Netherlands |
Other Details:
|
Languages: eng Pagination: 477-89 Citation Subset: IM |
Affiliation:
|
Belgian Healthcare Knowledge Centre (KCE), Brussels, Belgium. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Electronic prescribing by the numbers.
Next Document: Consent forms in genomics: the difference between law and practice.