In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

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1   Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
  1. a) instructions for instrument servicing or repair;
  2. b) IVD reagents, including calibrators and control materials for use in control of the reagent;
  3. c) IVD instruments for professional use.