Keeping the CE mark updated requires continuous observation on the latest regulatory requirements. We will explain to you what to do when European directives and standards are updated or replaced, just continue reading.
Similarly to the thorough risk analysis‘s conduction for the original product, you must carry out a risk analysis after every update or change of the product. The risk analysis assesses how the changes may affect product safety features. Moreover, it determines how you should verify them against all relevant CE requirements and standards.
Specific changes, such as aesthetic alterations or additions, changes to symbols or equivalent, don’t present any risk of altering product safety features. In such cases, you need to update the technical documentation that proves compliance with the CE requirements.
Many changes (even small aesthetic alterations) can affect product performance regarding electrical safety and EMC. For example, an aesthetic modification, like adding a varnish paint on the product cover, could affect the product’s grounding properties. Therefore, it will further impact the LVD and EMC requirements. If you’re in such a situation, you need to verify (test) the product against all relevant standards after the update. Afterwards, you must update the technical documentation and issue a new Declaration of Conformity.
Sometimes, it may be difficult to assess if and how product changes are to be regulated. In such cases, you have to consult with a market surveillance authority or a notified body.
If a standard should change, you may need to retest the product. Updates to ENs (European Standards) are ongoing and can sometimes be simply editorial. However, the updates sometimes contain significant changes about how to verify the safety of products. Therefore, you must consider carefully each change to see whether it affects your product or not.
If the harmonized standard applied becomes invalid by passing its date of cessation, the presumption of the directive in question will also terminate. In other words, you’ll no longer be able to claim that the product, by the presumption method, complies with the CE directive’s requirements. In such a situation, you should consider updating the product’s technical documentation to the subsequent valid standard version.