Stress free guide to product compliance

2021-03-11
ProductIP
Intermediate

Instruction Manuals

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

Manuals image

Always send the instruction manual in the correct language together with the product

Product legislation often includes the same requirement: manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users. The information and labelling, shall be clear, understandable, intelligible and legible.

Consumers shall be provided with all the necessary information for the safe use of the product.
This information shall be given in the most accessible, low-threshold manner. In practice this means that the information is provided on paper in the same packaging as the product and it must be in the local language.
It is NOT sufficient to use a QR code or to mention a website where the required information can be found instead.

Always available on paper, for free

Safety information must be provided on paper (in printed from). Mandatory instructions defined by legislation and standards must also be provided on paper. Other instructions may also be provided on electronic or or other data storage format. However, a paper version must always be available free of charge to consumers who request it.

Mandatory safety information, instructions and warnings

Several directives require that the product is accompanied by the "required documents", these documents are typically the safety and performance information, instructions and warnings. Manufacturers have to look further than the intended use of a product. They have to place themselves in the position of the average user and foresee the reasonably expected use and even misuse of the product. They also have to consider use of the products by others than the intended target users, for instance consumers using professional products.

Always refer to all the applicable directive(s), regulation(s) and standard(s) for full details on the mandatory information that shall be provided to the user. There are many topics that could be applicable:

SAFETY

INSTRUCTIONS

LANGUAGE

WARNINGS

PERFORMANCE

END USERS

SUPERVISION

USE & MISUSE

HAZARDS

SAFEGUARDS

EXPOSURE

PROTECTION

RESTRICTIONS

DRAWINGS

EXPLANATIONS

SPECIFICATIONS

SOFTWARE

SETTINGS

SECURITY

CONNECTIONS

ACCESSORIES

ASSEMBLY

INSTALLATION

DURABILITY

MAINTENANCE

STORAGE

REPAIR

TRANSPORT

RECYCLING

DISPOSAL

DEFECTS

FAQ

LEGAL

CONTACT

VERSION, DATE

 

Obligation for the entire supply chain

The manufacturer, importer and distributor each have the obligation to ensure that the product is accompanied by instructions in a language which can be easily understood by the users. This could mean that the importer or distributor has to take care of the translation when the information is not provided in the required language(s).
The legislation does not specify which economic operator is responsible for translations.

Guidelines for writing instruction manuals

Standard EN IEC/IEEE 82079-1:2020 provides principles and general requirements for the writing of instructions for use of products. The standard supersedes EN 82079-1:2012 and before that EN 62079:2001. Although the standard is best known for electrical products, it can be applied to a very wide range of products.
For machinery the harmonised standard EN ISO 20607:2019 applies to the instruction handbook.

Declaration of Conformity

A copy of the EU Declaration of Conformity must be provided with machinery, radio equipment, personal protective equipment, gas fittings and measuring instruments. For construction products a Declaration of Performance (DoP) must be provided. These copies can be provided separately but they are often included in the user manual.

Electrical appliances: not one but two locations

Standard EN 60335-1 specifies the general safety requirements for household and similar electrical appliances.
The harmonised amendment EN 60335-1:2012/A2:2019 adds the following requirement about instructions:
"In addition, instructions shall also be available in an alternative format such as on a website or on request from the user in a format such as a DVD."
This means that for these products the instruction manual must be provided on paper with the product and at the same it shall be available in another "alternative" format, most likely as download on the manufacturer's website.

Recalls

Just a handful of recent product recalls related to instructions: "the product does not provide adequate instructions on its use", "the product does not have instructions in national language for safe use", "the instructions for use do not contain some indications and warnings", "the product lacks the compulsory instructions manual with the warnings and precautions for its safe use","lack of instructions for a broken bulb can result an electric shock for users", "the product does not have any instructions on the replacing of the cord".

Get the required documentation right; prevent unsafe use of products and avoid recalls!

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