Paragraph 4
The manufacturer shall present the manufactured products to the notified body in the form of homogeneous batches.
A random sample shall be taken by the notified body from each batch.
The devices which make up the sample shall be examined individually and appropriate tests, defined in the relevant national Standards or equivalent tests, shall be carried out to verify the conformity of the devices with the type described in the EC type-examination certificate, in order to determine whether the batch is to be accepted or rejected.
Statistical control of products will be based on attributes, entailing a sampling system with the following characteristics:
a level of quality corresponding to a probability of acceptance of 95%, with a non-conformity percentage of between 0.29 and 1%;
a limit quality corresponding to a probability of acceptance of 5%, with a non-conformity percentage of between 3 and 7%.
If a batch is accepted, the notified body shall draw up a written certificate of conformity, and all the devices in the batch may, subject to regulation 3(1), be placed on the market, with the exception of those devices in the sample which were found not to conform.
If a batch is rejected, the notified body shall take the appropriate measures to prevent the batch from being placed on the market.
If justified on practical grounds, the manufacturer may affix the EC mark during manufacture, under the responsibility of the notified body, in accordance with regulation 4(1), accompanied by the identifying logo of the notified body responsible for statistical verification.