| Literature DB >> 16419921 |
A W van Drongelen1, B Roszek, E A E van Tienhoven, R E Geertsma, R T Boumans, J J A M Kraus.
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.Entities:
Mesh：
Year: 2005 PMID： 16419921
Source DB: PubMed Journal: Med Device Technol ISSN： 1048-6690