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EN 13612:2002/AC:2002 Standard

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  Keywords:

#ivd #manufacturer #performance #mds #design

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Thursday 15th of April 2021

  Description:

Performance evaluation of in vitro diagnostic medical devices

  Purpose

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.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN 13612:2002"

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