Legal implications of new interventional devices and procedures

Autor:	M R E Dean
Rok vydání:	2000
Předmět:	medicine.medical_specialty Medical device business.industry medicine Radiology Nuclear Medicine and imaging Medical emergency medicine.disease business Medical ethics Surgery
Zdroj:	Imaging. 12:249-251
ISSN:	1748-8818 0965-6812
DOI:	10.1259/img.12.4.120249
Popis:	•. The regulations for the introduction of new medical devices are now standardized across the European Community.•. Before a new medical device can be marketed it must obtain a CE Mark.•. A medical device that does not have a CE Mark may only be used as part of a scientifically designed trial that has the approval of the MDA.•. Permission for such a trial must be obtained from the Local Medical Ethics Committee.•. New and unproven interventional procedures should be registered in the UK with the Safety and Efficacy Register for New Interventional Procedures (SERNIP).•. Compliance with the advice of SERNIP remains voluntary, but interventional radiologists are strongly advised to observe its recommendations.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::ad8653fe5b0d260de8b5617df13c8dff https://doi.org/10.1259/img.12.4.120249 Zobrazit plný text záznamu