Extract from 2023/988/EU Regulation
Section 1 Article 9
Obligations of manufacturers
(1) When putting their devices on the market, manufacturers shall ensure that those devices have been designed and manufactured in compliance with the general safety requirement standards stipulated in Article 5.
(2) Before placing their devices on the market, manufacturers shall carry out an internal risk analysis and draw up a technical documentation including at least a general description of the device and its essential characteristics relevant for the assessment of its safety.
(3) Manufacturers shall ensure that the technical documentation referred to in paragraph 2 is kept up to date. They shall keep that documentation at the disposal of the market surveillance authorities for a period of 10 years after the product has been placed on the market and shall make it available to those authorities upon request.
(4) Manufacturers shall ensure that appropriate procedures are in place to ensure that products manufactured in series always comply with the general safety requirement standards stipulated in Article 5.
(5) Producers shall ensure that their products bear a type, batch or serial number or similar element that is easily recognizable and legible by consumers thus allowing their identification, or, where the size or nature of the device does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
(6) Manufacturers shall indicate their name, registered trade name or registered trademark, postal address and ►C1 electronic address ◄ and, where different, the postal or ►C1 electronic address ◄ of the single contact point at which they can be contacted. This information shall be specified on the product itself or, if this is not possible, on the packaging or in a document accompanying the product. * ►C1 Latest consolidated version: 23/05/2023
(7) Manufacturers shall ensure that their product is accompanied by clear instructions and safety information in a language which can easily be understood by consumers and which is decreed by the Member State in which the product is made available on the market. This requirement shall not apply if the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Section 2 Article 21
Information in electronic form
Without prejudice to Article 9(5), (6) and (7), Article 11(3) and Article 16(3) and the relevant provisions of Union harmonization legislation, economic operators may additionally provide the information referred to in those provisions in digital form by means of electronic technical solutions that are clearly visible on the product or, if not possible, on its packaging or in a document accompanying the product. That information shall be provided in a language that can easily be understood by consumers, as decreed by the Member State in which the product is made available on the market, including in formats accessible and comprehensible to persons with disabilities.