EU and US Regulations on Instructions for Use: Find the Differences! (Part 2)

In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for instructions for use.
Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

Last week, Ferry Vermeulen and Michael Gerrits, discussed the EU requirements for insin the EU. In the next part, which is published next week, the US requirements for instruction for use are laid out, and a comparison is made with the EU rules.

EU and US Regulations on Instructions for Use: Find the Differences! (Part 1)

User Manual

In the EU, a manufacturer can use European harmonized standards to comply with the relevant essential health and safety requirements of the CE marking directives and accordingly affix CE marking. Many of these CE marking directives also set requirements for instructions for use.
Although there are many similarities, the process of product compliance in the US is slightly different from the process of EU compliance.

In this part, Ferry Vermeulen and Michael Gerrits, describe the requirements in the EU. In the next part, which is published next week, the US requirements for instruction for use are laid out, and a comparison is made with the EU rules.

How to Comply Your Manual With American Standards?

Instruction Manual

In Europe, a manufacturer can use European harmonised standards to comply with CE-directives and accordingly affix the CE marking. Safety companies in North America, like UL, have their own standards, which have to be taken into account when exporting to the US. Standards related to instructions of use may be similar but also vary depending on the market where you intend to place your product. Let’s take a look at the American ANSI Z535.6 standard.

The User Manual As Part of CE Marking

User Manual

The European New Approach Directives form the starting point of the CE marking (Conformité Européenne). In these directives, user manuals are also discussed extensively. What do the European New Approach Directives mean and what do they mean for you and the user manuals of your products?