10164086

Source:http://linkedlifedata.com/resource/pubmed/id/10164086

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Predicate	Object
rdf:type	pubmed:Citation
lifeskim:mentions	umls-concept:C0037747, umls-concept:C0599437
pubmed:dateCreated	1997-2-11
pubmed:abstractText	In Spain, only the Active Implantable Medical Device Directive has been transposed into national legislation, with the Medical Device Directive relevant Decree still in a draft edition. However, the notification of serious adverse incidents is compulsory for manufacturers and users, both for CE-marked devices and non CE-marked devices. Manufacturers of all medical devices classes must be registered at the national competent authority, though the directives do not require it.
pubmed:language	eng
pubmed:journal	http://linkedlifedata.com/resource/pubmed/journal/9214582
pubmed:citationSubset	T
pubmed:status	MEDLINE
pubmed:issn	0926-9630
pubmed:author	pubmed-author:LunaC ACA
pubmed:issnType	Print
pubmed:volume	28
pubmed:owner	NLM
pubmed:authorsComplete	Y
pubmed:pagination	112-5
pubmed:dateRevised	2007-11-15
pubmed:meshHeading	pubmed-meshheading:10164086-Equipment and Supplies, pubmed-meshheading:10164086-Guidelines as Topic, pubmed-meshheading:10164086-Legislation, Medical, pubmed-meshheading:10164086-Product Surveillance, Postmarketing, pubmed-meshheading:10164086-Spain
pubmed:year	1996
pubmed:articleTitle	Spain's competent authority initiatives.
pubmed:affiliation	Spanish Ministry of Health, Madrid, Spain.
pubmed:publicationType	Journal Article