F1SCHEDULE 1BCONFORMITY ASSESSMENT PROCEDURES (Annex II to the Directive)

Annotations:

MODULE H1:CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

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The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up and shall mention the number of the design examination certificate.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.