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.