EVS-EN 13612:2002

EN 13612 applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or specific use. Where a manufacturer maintains a quality system EN 13612 addresses compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928.

EN 13612 helps to:

– show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,

– establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to

– satisfy the requirements of a quality system for design validation.