Regulation (EC) No 1394/2007 Article 7

Specific requirements for advanced therapy medicinal products containing devices

Article 7

In addition to the requirements laid down in Article 6(1) of Regulation (EC) No 726/2004, applications for the authorisation of an advanced therapy medicinal product containing medical devices, bio-materials, scaffolds or matrices shall include a description of the physical characteristics and performance of the product and a description of the product design methods, in accordance with Annex I to Directive 2001/83/EC.

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Other provisions in CHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 7 of Regulation (EC) No 1394/2007 (LawPlayer, data as of 2026-07-04)

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