title: Annex II technical documentation assessed.
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.
authors.affiliation: Centre for Biological Medicines and Medical Technology, Dutch National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. arjan.van.drongelen@rivm.nl
authors.forename: A W
authors.initials: AW
authors.lastname: van Drongelen
authors.forename: B
authors.initials: B
authors.lastname: Roszek
authors.forename: E A E
authors.initials: EA
authors.lastname: van Tienhoven
authors.forename: R E
authors.initials: RE
authors.lastname: Geertsma
authors.forename: R T
authors.initials: RT
authors.lastname: Boumans
authors.forename: J J A M
authors.initials: JJ
authors.lastname: Kraus
mesh_terms: D004282:Documentation; D004864:Equipment and Supplies; D019451:Information Management / Q000331:legislation & jurisprudence / Q000592:standards*; D011786:Quality Control