Council Directive 93/42/EECShow full title

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

[F19. Application to devices referred to in Article 1(4a) U.K.

In the case of section 5, upon completing the manufacture of each batch of devices referred to in Article 1(4a), and in the case of verification under section 6, the manufacturer shall inform the notified body of the release of this batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with [F2Article 114(2) of Directive 2001/83/EC] .]