Regulation (EC) No 1394/2007 Article 6

Issues specific to medical devices

Article 6

1. A medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex I to Directive 93/42/EEC. 2. An active implantable medical device which forms part of a combined advanced therapy medicinal product shall meet the essential requirements laid down in Annex 1 to Directive 90/385/EEC.

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

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