Am I obliged to recertify my product, when a Directive, Regulation or standard is altered?

When a Directive, Regulation, or standard related to your product is altered, it may impact the CE marking of your product, and in some cases, you may need to recertify or reevaluate your product’s compliance.

Template Declaration of Conformity

Products that are already on the market

A product which is already been placed onto the EU market and which has, at that time, been certified in accordance with the applying directive(s), regulation(s) and/or (harmonised) standard(s), do not have to be re-certified.

Products that have not been put onto the EU market yet

New products that are placed on the market need to be in accordance with the applicable directives, regulations and standards that apply at that time.

Products, to which important changes have been made with the intention of altering the original operation, the original goal or type, after the product has already been used, for instance by using other components or new deliverers, can be regarded as new products.

Things to consider

  1. Nature of Changes: If the changes to the directive, regulation, or standard are significant and impact the essential requirements or safety aspects relevant to your product, you may need to reassess your product’s compliance. Minor administrative changes or non-essential alterations may not necessitate recertification.
  2. Transitional Periods: Regulatory changes may come with transitional periods during which the old and new requirements are both acceptable. During this transition, you may have some time to adapt your product to the updated regulations.
  3. Notified Body Involvement: If you previously required the involvement of a Notified Body for conformity assessment (e.g., for certain machinery, medical devices, or high-risk products), it’s important to consult with them to determine if recertification is necessary based on the changes.

Conclusion

The need for recertification when regulations change is a case-by-case matter. You should carefully assess the specific changes, consult with relevant authorities or experts, and ensure your product remains in compliance with the updated requirements. Failure to adapt to new regulations could affect the legality of your product’s placement on the market and the safety of end-users.

Also you, as manufacturer, are responsible for the safe usage of your product. If important alterations have been made to the directives, regulations and/or (harmonised) standards that apply to your product, please feel free to contact us so we can help you with recertification.

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