Performance evaluation of in-vitro diagnostics

The evaluation must meet the requirements of the In-vitro Diagnostics Decree relating to performance evaluations, as well as the requirements which govern clinical testing involving human subjects and the scientific state of the art.

There are also a number of relevant ISO standards covering clinical research, which include useful suggestions. These standards are available from NEN (the Dutch standards institute) www.nen.nl

A performance evaluation study has to be notified to the Dutch Health Care Inspectorate. There is no specified format available for this notification. However, you may send the declaration as referred to in annex 8 of the Dutch Decree of in vitro diagnostic medical devices (i.c. annex 8 of the European Directive) to the inspectorate: 

Dutch Health Care Inspectorate
For the attention of program medical technology - inspector for IVDs
P.O. Box 2680 
3500 GR Utrecht 
The Netherlands
Fax: +31 88- 120 50 01 
meldpunt@igz.nl