The IVD Directive defines a device for performance evaluation as "any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside their own premises". 
 
 
The term “performance evaluation” is not defined in the IVDD; however, it is defined in the European harmonised standard, EN 13612:2002, 'Performance evaluation of in vitro diagnostic medical devices'. The standard states that “performance evaluation” means “investigation of the performance of an in vitro diagnostic medical device based upon data already available, scientific literature and/ or performance evaluation studies”. The standard defines “performance evaluation studies” as “investigation of an in vitro diagnostic medical device intended to validate the performance claims under the anticipated conditions of use”.
 
 
IVDD Annex III, Section 3, indent 11 'EC Declaration of Conformity', states that device technical documentation must include “adequate performance evaluation data showing the performances claimed by the manufacturer and supported by a reference measurement system (when available), with information on the reference methods, the reference materials, the known reference values, the accuracy and measurement units used; such data should originate from studies in a clinical or other appropriate environment or result from relevant biographical references”.
 
 
Evidence of performance claims is required for all IVD devices; however, the particular IVD device and the risks associated with its use will determine whether the evaluation is based upon data already available, scientific literature and/or performance evaluation studies.
 
 
When manufacturers wish to conduct performance evaluation studies, they must comply with Article 9(4) of the IVDD, which requires that they follow the procedure referred to in Annex VIII, 'Statement and Procedures Concerning Devices for Performance Evaluation', and draw up the statement set out in that Annex before such devices are made available for the studies.
 
 
The IVDD does not require notification of the competent authorities in the countries where performance evaluation studies are being performed. Instead, the IVDD, in section 4 of Annex VIII, requires that devices for performance evaluation are registered with the competent authority of the country in which the manufacturer or authorised representative is established. However, manufacturers should determine the existence of any national requirements for notification before study initiation.
 
 
GEMAR can help prepare performance evaluation study protocols, satisfying all the European regulatory requirements and assist in the performance evaluation planning, management and monitoring.