In the case of devices covered by Annex II, List A, the manufacturer shall forward to the notified body without delay after the conclusion of the controls and tests the relevant reports on the tests carried out on the manufactured devices or each batch of devices. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities.

The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed time-frame, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates.