# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 8: Application to the devices referred to Article 1(4a)

Extent: E+W+S+N.I.

Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the 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 Article 114(2) of Directive 2001/83/EC .

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/II/division/8 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-II/division-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.