3. Instrument checks

At the choice of the manufacturer, either an accredited in-house body or a notified body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks on the instrument, taking into account, inter alia, the technological complexity of the measuring instruments and the quantity of production. An adequate sample of the final measuring instrument, taken on site by the accredited in-house body or by the notified body before the placing on the market, shall be examined and appropriate tests, as identified by the relevant parts of the harmonised standards, and/or normative documents, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instrument with the type described in the EU-type examination certificate and with the relevant requirements of this Directive. Where a sample does not conform to an acceptable quality level, the accredited in-house body or notified body shall take appropriate measures. The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the instrument performs within acceptable limits, with a view to ensuring conformity of the instrument. Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.