Version detected , Modified +6 −6§
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Explanation, written by a model and checked against the cited text
In paragraph 15, the cross-reference to the provision governing submission of information on the identity of the person designing or manufacturing the device has been changed from Article 30(1) to Article 29(4).
Cited: Art. 10, v1 (external, EUR-Lex) · Art. 10, 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 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 … 1,251 unchanged words … the context of legal proceedings.
15. 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 30(1). 29(4).
16. 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.