CE Compliance Addendum Reports: what are they?

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 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:

  1. Review the machine’s previous CE report and technical file
  2. Review the changes to the machine’s composition (BOM, schematics, supporting documentation for changed/added components)
  3. Produce a draft addendum report for your review and feedback
  4. Provide the final addendum report
  5. 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.

ce compliance mark lewis bass blog post example image

Do you need a quote for a CE Compliance Report Addendum?

Do you have a need for any of our other services?

Lewis Bass can help your team identify the most common safety issues in your facility, along with providing immediate referrals to our trusted partners to address them on your behalf.

Not sure what service you need from us?

Take our service identifier quiz here.

Are you uncertain if your equipment is unlisted or not at your facility?

Lewis Bass has you covered here as well: download our unlisted equipment self-identification flyer here.

Do you have a need for an urgent machinery evaluation?

Please reach out to us using our contact form here or call/text us directly on our office line 408-942-8000. We are always available to help with rush jobs and permit-blocking safety situations at your facility.

Lewis Bass International Engineering Services