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Med Device Technol
; 16(10): 21-3, 2005 Dec.
Article
in English
| MEDLINE
| ID: mdl-16419921
ABSTRACT
Annex II of the Medical Device Directive (MDD) is used frequently by manufacturers to obtain CE-marking. This procedure relies on a full quality assurance system and does not require an assessment of the individual medical device by a Notified Body. An investigation into the availability and the quality of technical documentation for Annex II devices revealed severe shortcomings, which are reported here.