A legally compliant, clear operating/technical manual is a key requirement in the EU market
For manufacturers of machinery, electrical appliances, construction materials, and medical devices entering the EU or Great Britain markets.
Valid until the design or legislation changes; must be kept up to date and translated into the languages of the countries of sale (Blue Guide 2022 §4.5).
A document that accompanies the product and sets out safe conditions for installation, operation, maintenance, and disposal. In the EU, its format is governed by sector-specific regulations and harmonised standards (e.g., EN 82079-1 for machinery).
It must be translated into the official language of the country of import (Blue Guide 2022).
It may be supplied in electronic form if permitted by the sectoral act (e-IFU for medical devices).
It must include the manufacturer’s identification details, labelling, safety pictograms, and a list of spare parts.
Alstera will develop a multilingual manual and ensure compliance with EN 82079-1 and ISO 7010 pictogram design.
Yes, if permitted by the sectoral regulation (for example, the Machinery Regulation 2023/1230 allows an e-manual, but the user may request a printed copy free of charge).
The manufacturer or the authorized representative. The importer must verify its accuracy before placing the product on the market (Art. 4 of Regulation (EC) 765/2008)
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