| [Medical innovations in the area of conflict between certification and allowance]. | |
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MedLine Citation:
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PMID: 20941684 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The medical technology industry is one of the most innovative industries in Germany. Once a medical product is developed, it will be certificated according to European harmonized guidelines and norms. The respective national regulations in Germany are stipulated in the Medical Devices Act (MPG). Part of the certification process is a clinical assessment with the aim to prove that the medical device complies with the so-called essential requirements concerning safety, performance and suitability for the intended use as defined by the manufacturer. A clinical trial may be necessary to establish compliance with these requirements. During this clinical trial the devices are being assessed in patients according to strict requirements by law. The main criticism by the funding agencies is that these trials do not sufficiently apply methods of evidence-based medicine. Thereby they are not useful for assessing the medical benefit of the devices. The manufacturers' counter-argument is that the products are bearing the CE mark, that they comply with the uniform European standards and that their quality therefore has been appropriately assessed. This discussion relates to the question about payment for the products, as according to the Fifth Social Act the funding agencies are only permitted to finance products with a scientifically proven medical benefit. The present article discusses both positions in the context of national and international legislation for the certification of medical devices and presents possible solutions. |
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Authors:
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B Möller; M Stockheim; T Kraus; A Weber |
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Publication Detail:
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Type: English Abstract; Journal Article Date: 2010-10-12 |
Journal Detail:
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Title: Deutsche medizinische Wochenschrift (1946) Volume: 135 ISSN: 1439-4413 ISO Abbreviation: Dtsch. Med. Wochenschr. Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-10-13 Completed Date: 2010-10-29 Revised Date: 2010-12-23 |
Medline Journal Info:
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Nlm Unique ID: 0006723 Medline TA: Dtsch Med Wochenschr Country: Germany |
Other Details:
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Languages: ger Pagination: 2088-92 Citation Subset: IM |
Copyright Information:
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© Georg Thieme Verlag KG Stuttgart · New York. |
Affiliation:
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Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e.V., Essen. b.moeller@mds-ev.de |
Vernacular Title:
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Medizintechnische Innovationen im Spannungsfeld zwischen Zertifizierung und Vergütung. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Certification
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economics*,
legislation & jurisprudence* Clinical Trials as Topic / economics, legislation & jurisprudence Cost-Benefit Analysis / legislation & jurisprudence Device Approval / legislation & jurisprudence* Evidence-Based Medicine / economics, legislation & jurisprudence Germany Guideline Adherence / economics, legislation & jurisprudence Humans National Health Programs / economics*, legislation & jurisprudence* Quality Assurance, Health Care / economics, legislation & jurisprudence Technology, Medical / economics*, legislation & jurisprudence* |
| Comments/Corrections | |
Erratum In:
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Dtsch Med Wochenschr. 2010 Dec;135(50):2505 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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