EU regulatory register · PRODUCT-LIABILITY
Article 4Definitions
CELEX 32024L2853 · Read on 2026-08-22
Official text
Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.
For the purposes of this Directive, the following definitions apply:
(1)
‘product’ means all movables, even if integrated into, or inter-connected with, another movable or an immovable; it includes electricity, digital manufacturing files, raw materials and software;
(2)
‘digital manufacturing file’ means a digital version of, or digital template for, a movable which contains the functional information necessary to produce a tangible item by enabling the automated control of machinery or tools;
(3)
‘related service’ means a digital service that is integrated into, or inter-connected with, a product in such a way that its absence would prevent the product from performing one or more of its functions;
(4)
‘component’ means any item, whether tangible or intangible, raw material or related service, that is integrated into, or inter-connected with, a product;
(5)
‘manufacturer’s control’ means that:
(a)
the manufacturer of a product performs or, with regard to actions of a third party, authorises or consents to:
(i)
The article continues in the official text.
Judgments of the Court of Justice
1 decisions
- C-621/15Court of Justice of the European Union
N. W and Others v Sanofi Pasteur MSD SNC and Others
Reference for a preliminary ruling — Directive 85/374/EEC — Liability for defective products — Article 4 — Pharmaceutical laboratories — Vaccination against hepatitis B — Multiple sclerosis — Proof of defect of vaccine and of causal link between the defect and the damage suffered — Burden of proof — Methods of proof — Lack of scientific consensus — Serious, specific and consistent evidence left to the discretion of the court ruling on the merits — Whether permissible — Conditions.
The text is quoted from the official source and is not legal advice. A national court reads the language version that binds in its jurisdiction.
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