Ferry Vermeulen will be presenting on “US regulations on instructions for use”.
In the EU, a manufacturer can use European harmonized standards to comply with CE-directives and accordingly affix the CE marking. Although there are many similarities, the process of compliance in the US is slightly different from the process of EU compliance. These differences have effect on the instructions for use that accompany a product. When exporting from the EU to the US, the differences should be taken into account, so also the instructions comply with all laws and product liability will be minimized.