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PubMed · 16419921

Annex II technical documentation assessed.

A W van Drongelen·B Roszek·E A E van Tienhoven·R E Geertsma·R T Boumans·J J A M Kraus
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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.

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A W van Drongelen, B Roszek, E A E van Tienhoven, R E Geertsma, R T Boumans, J J A M Kraus. 2005. Annex II technical documentation assessed.. https://pubmed.ncbi.nlm.nih.gov/16419921/

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