This European Standard 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 a specific use.
NOTE For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with
design validation and design changes as described in EN ISO 9001, EN 46001 and EN 928
especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs 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.
Diese Norm gilt für die Leistungsbewertung von In-vitro-Diagnostika, einschließlich solcher zur Eigenanwendung. Sie legt die Verantwortlichkeiten und allgemeinen Erfordernisse zur Planung, Durchführung, Auswertung und Dokumentation einer Leistungsbewertungsstudie durch den Hersteller fest.