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Provision history · IVDR

Art. 10 · General obligations of manufacturers

In Vitro Diagnostic Medical Devices Regulation · 32017R0746 · every version of this act · on EUR-Lex

1 change recorded across 1 version, newest first.

Twin in Medical Devices Regulation: Art. 10, textually similar (0.931), paired on this act's text of 10 January 2025 and the Medical Devices Regulation text of 19 July 2026. See where the two texts differ.

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Version detected Modified +6 −6

no amending act named

Applies from: no date changed

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

In paragraph 14, the cross-reference for where identity information on a designer or manufacturer of the device must be submitted was changed from Article 27(1) to Article 26(3).

Cited: Art. 10, v1 · Art. 10, v2

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version 32017R0746 → this version, detected 12 August 2026 02017R0746-20170505

Article 10 General obligations of manufacturers 1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. 2. Manufacturers shall establish, document, implement … 1,242 unchanged words … the context of legal proceedings. 14. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1). 26(3). 15. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.