Annex II technical documentation assessed.
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.
van Drongelen
A W
AW
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
Roszek
B
B
van Tienhoven
E A E
EA
Geertsma
R E
RE
Boumans
R T
RT
Kraus
J J A M
JJ
D004282:Documentation; D004864:Equipment and Supplies; D019451:Information Management / Q000331:legislation & jurisprudence / Q000592:standards*; D011786:Quality Control