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Provision history · Medical Devices Regulation

Art. 7 · Claims

Medical Devices Regulation · 32017R0745 · every version of this act · on EUR-Lex (external, EUR-Lex)

1 change recorded across 1 version, newest first.

Twin in IVDR: Art. 7 (external, EUR-Lex), textually similar (0.989), paired on this act's text of 19 July 2026 and the IVDR text of 10 January 2025. See where the two texts differ.

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Version detected , Modified +12 −11

no amending act named

Applies from: no date changed

Explanation, written by a model and checked against the cited text

The only change in this provision is that the term "trademarks" is now spelled as two words, "trade marks".

Cited: Art. 7, v1 (external, EUR-Lex) · Art. 7, v2 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version 32017R0745 → this version, detected 12 August 2026 02017R0745-20170505

Article 7 Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.