CE Compliance Addendum Reports: what are they?
CE compliance addendum reports are a clear, simpler path forward over a full CE compliance report.
These addendum CE compliance reports are specifically drafted in situations where previously evaluated systems have received minimal revisions due to either parts scarcity, redesigns specified by the end user, name changes, or other functional adjustments.
For example, if a previously certified product needs a new sub-assembly, like a chiller or heating element, instead of undergoing the entire CE certification process again, an addendum report suffices. This streamlined approach is particularly beneficial for maintaining CE compliance without the need for exhaustive re-evaluation.
Cost Savings
The cost of preparing and drafting an addendum report can also be of great savings to your budget; as the cost for generating this type of report can be up to 2/3 less in cost than a full CE evaluation.
Faster Time to Market
Drafting a CE mark addendum report reduces the longer timeline associated with achieving full CE compliance, making it an efficient solution for manufacturers facing supply chain issues or customer-driven redesigns needing immediate resolution for shipment to their customers, as the time spent taking measurements and reviewing documentation has already been performed in the previous CE evaluation of the system.
Addendum CE Compliance Reports Are Applicable to Many Industries
In the medical device sector manufacturers often need to make minor updates to their products due to advances in technology or changes in materials. Addendum reports fill this need for iterating on already proven technologies. Similarly, in the automotive industry, addendum reports can accommodate updates in vehicle components without necessitating a full re-certification process, which is especially crucial in today’s competitive EV markets.
CE addendum reports are commonly used in the industrial machinery sector, which frequently adapts its equipment to meet specific client needs or incorporate new safety features. The faster delivery associated with these addendum reports helps to keep manufacturers from falling behind their peers in safety compliance at their facilities.
By leveraging these addendum reports, these industries can maintain CE compliance efficiently, ensuring that their products continue to meet stringent European standards while adapting to market demands and technological advancements.
What is the Process for Performing a CE Compliance Addendum Report?
To prepare for a CE compliance addendum report, our engineering team will follow the below outlined process with your company:
- Review the machine’s previous CE report and technical file
- Review the changes to the machine’s composition (BOM, schematics, supporting documentation for changed/added components)
- Produce a draft addendum report for your review and feedback
- Provide the final addendum report
- Sign the CE Declaration of Conformity for your system
CE compliance addendum reports performed on systems that have been previously evaluated for compliance to CE Mark Directives are evaluated against the changes in the BOM, schematics, and provided documentation for the modified system.
The resulting CE compliance addendum report provides the delta of the changes in the system, which can then be outlined and noted in the addendum report along with supporting verbiage stating that the modifications are still within the acceptable ranges of conformity per each CE Directive it was evaluated against.
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