In vitro diagnostic medical devices (IVD) must achieve the performance declared by the manufacturer, in particular, as appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including the control of the known relevant interferences with other products, and with regard to the detection limit of the examined parameter.
The manufacturer demonstrates that these requirements are met by a combination of relevant scientific literature and performance studies. Depending on the type of IVD, the validation of this data is certified by a notified body or by self-certification.
Legislation applicable to medical devices used in clinical studies
- European directives
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
- National legislation
- Royal Decree dated 14/11/2001 (French version)
- http://ec.europa.eu/growth/sectors/medical-devices/guidance_nl(link is external)
- http://www.imdrf.org/documents/documents.asp(link is external)