# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 3.4.1: Advanced therapy medicinal product containing devices as referred to in Article 7 of Regulation (EC) No 1394/2007

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

A description of the physical characteristics and performance of the product and a description of the product design methods shall be provided.
The interaction and compatibility between genes, cells and/or tissues and the structural components shall be described.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/3/division/3.4/division/3.4.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.4/division-3.4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.