When I modify my product should I re-certify again?

The need for re-certification when modifying a product depends on the nature and extent of the modification, as well as the regulatory requirements applicable to the product.

Substantial Modification

A substantial modification is a modification of a product after that product has been placed on the European market or put into service. The modification is either by physical or digital means and is not foreseen or planned by the manufacturer. Further the modification affects the safety of that product by creating a new hazard or by increasing an existing risk and requires the addition of guards, protective devices or other protective measures.

When such modifications occur, the certification process must be carried out once again, possibly on the basis of the previous certification, and a new EC Declaration of Conformity, in accordance with new guidelines and / or standards must be compiled.

Minor Modifications

Minor modifications that do not impact the safety or regulatory compliance of a product, may not require re-certification. It’s crucial to exercise caution and ensure that even minor modifications are handled diligently to maintain compliance with EU regulations. Keep in mind that the responsibility for confirming compliance rests with the manufacturer, so documenting the entire process is essential.

Regulatory Requirements

Be aware of the specific regulations and standards that apply to your product category. Some regulations may stipulate that even minor changes trigger a re-certification process, while others may provide more flexibility.

Key Considerations for Product Modifications

It’s important to note that in cases where re-certification is necessary, the process can be time-consuming and may require additional testing and evaluation. Failing to re-certify a modified product when required can result in non-compliance with regulatory standards, potential safety hazards, and legal consequences.

When the modification doesn’t alter the entire product, it’s possible to base the certification of the modified product on the existing certification. This approach can offer cost savings.

To ensure that your modified product remains in compliance, you can contact us.


Related articles

Full-service product compliance

Leave it to us.

ISO27001 & ISO9001 – Trusted by 300+ Clients.