What is product compliance?

Product conformity, product compliance and product safety are all terms that refer to regulatory requirements but can be very confusing. In this EFS RegCom Academy article, we take a look at the basics of product compliance. This in turn is part of the umbrella term “Regulatory Compliance”, which is described in more detail here.

What is product compliance?

Compliance is “conformity with laws, rules, norms and standards”. This means that companies are obliged to comply with the regulations that apply to their product. This obligation extends across various levels of legislation on the one hand and across several areas on the other. It also applies not only to laws themselves, but also to product-specific standards and other technical standards (here you can find more information on the differences between laws, standards and directives).

Which product area is affected?

Product conformity concerns the entire period of the product life cycle. It therefore covers everything from product development and market launch to ongoing obligations after market launch. Depending on the product and country, this can also include an obligation to repair or even the final disposal of the product.

Who is responsible for product compliance?

The legal obligation to only place safe products on the market affects several stakeholders. Normally, these are the manufacturers if the products are sold in their own country. As soon as the product crosses a national border, the distributor is also held responsible. This can be an authorised representative of the manufacturer, but also the importer or the final distributor.

This results in a typical cascade: the distributor must normally ensure that the product fulfils all the necessary points such as product labelling, safety instructions, manuals, etc. The final responsibility for creating these must be borne by the manufacturer. In turn, the distributor must demand that the manufacturer or importer takes final responsibility for creating these.

More information on the objectives of product compliance can be found here.