In today’s blog, we’ll be looking at why your product CE marking may expire.
Jump Links
- Fire and Forget
- Regulation Change
- Changes to Product Specification or Design
- Change in Intended Use
- Manufacturing Process
- Document Obsolescence
- Notified Body Withdrawal
- Reassessment with Knox Thomas
Fire and Forget
Successfully navigating the CE compliance maze is a complicated and time-consuming task, so it would be nice if once you’ve done the necessary leg work, you could forget about it like a fire and forget missile of compliance.
The reality is not this simple though- there are multiple reasons why you may need to reassess your product for CE compliance.
The reasons why CE marking may become invalid are similar to the reasons why you may need to review any other form of risk assessment (which is essentially what CE marking is).
These are essentially following relevant regulation/legislation changes, when the product itself has changed, or the intended use has been modified.
Of course, here are other reasons that your CE marking may expire.
Let’s unpack each of these reasons.
Regulation Change
As CE marking demonstrates compliance with legislation, it stands to reason that your product may no longer comply should the legislation change. A bit like moving the goalposts of compliance.
So, if a directive or regulation has been updated, replaced or repealed, your product may need to be reassessed.
An example of this is the Machinery Directive 2006/42/EC which is being replaced by the new Machinery Regulation (EU) 2023/1230, which entails new obligations for manufacturers.
To keep on top of any changes to legislation, you may want to subscribe to updates from the European Commission or your chosen notified body who can track changes that may affect your current products.
Changes to Product Specification or Design
Earlier we mentioned moving the goalposts of compliance as a reason your CE marking could become invalid. We’re moving them again, but this time in relation to the design of your product.
Your CE marking may expire if your product is subject to significant modifications. These could be due to performance, to lower costs, or improve functionality; whatever the reason, the conformity assessments made on your product may no longer be valid.
So, if you have added new components or features, changed materials or control systems, or altered protective measures or even the software logic, chances are you’ll need to reassess your product.
Don’t let a minor change lull you into a false sense of security- whatever changes you make may affect compliance with essential health and safety requirements, causing your CE marking to expire.
Change in Intended Use
Your conformity assessment is essentially a risk assessment- and all good risk assessments take into account the activity and environment associated with the hazard.
In this case, the hazard(s) are relating to your product- however they are influenced by the way the product is used. If the way the product is used at the time of conformity assessment is altered, this may introduce additional hazards that were not accounted for originally- hence why your CE marking may expire.
For example, a product designed for general packaging being repurposed in the food processing industry would likely need compliance with hygiene requirements that were not part of the original assessment.
Similarly, a machine being repurposed for uses within an ATEX zone would require a completely different level of conformity.
It’s important to note that the definition of “intended use” is central to CE conformity; if that changes, your CE marking may expire.
Manufacturing Process
Your initial conformity assessment will have taken into account the manufacturing process- for example the suppliers of materials and parts, assembly methods, and even the production site.
Changes to these and other factors may introduce additional risks that were not covered by the original conformity assessment.
If this is the case, you may need to validate the new process for consistency with the original design, update risk assessments or associated controls, or re-run elements of your conformity assessment.
Document Obsolescence
So, the legislation surrounding your product hasn’t changed, your product design hasn’t altered, and the intended use has remained the same too. No chance that your CE marking may expire, right?
Unfortunately…wrong.
The technical file and Declaration of Conformity which you will have meticulously compiled at the time of assessment must be kept up to date and available for inspection for at least ten years after the product was last placed on the market.
So, if you’ve not maintained your records, or have even lost them, your CE marking may expire due to this non-compliance.
Notified Body Withdrawal
Some products’ CE mark is based on a third-party certification (for example Module B). Should the associated notified body lose its designation or withdraws your certificate, your CE mark will become invalid.
This is particularly relevant for higher risk categories such as pressure equipment, medical devices, or lifts, where involvement with a notified body is mandatory.
Reassessment with Knox Thomas
Most things to do with health, safety and the environment are not one-off, tick-box exercises. CE marking is no exception- it’s a live declaration that your product continues to meet applicable requirements.
In this blog we’ve looked at whether a CE mark can expire, however the more accurate wording would be for it to become invalid.
By way of summary, your CE mark may expire due to:
- Change to relevant laws or standards
- Your product itself changes
- The intended use is altered
- The manufacturing process is changed
- Outdated documentation
- Third party certification withdrawal
As a manufacturer, you have a responsibility to periodically review your products as well as manufacturing processes, and compliance status, to ensure your CE marking remains valid.
It’s particularly important to do this before product updates, audits, or market expansion.
Our bet however is that if you’re busy with these operational changes, taking an intense look at the CE compliance status of your products is just one more time-consuming headache that you could do without.
If you have a feeling that your CE marking may expire, and want some assistance in knowing for sure- get in touch.
FAQ
1. Does CE Marking expire?
CE marking is better described as becoming invalid rather than expiring. It is a live declaration that your product continues to meet applicable requirements, so if circumstances change, your CE marking may no longer be valid.
2. Can changes to my product make CE Marking invalid?
Yes. If your product is subject to significant modifications such as new components or features, changed materials or control systems, altered protective measures, or software logic, the original conformity assessments may no longer be valid.
3. Can regulation changes affect CE Marking?
Yes. If a directive or regulation has been updated, replaced or repealed, your product may need to be reassessed. For example, Machinery Directive 2006/42/EC is being replaced by Machinery Regulation (EU) 2023/1230, which introduces new obligations for manufacturers.
4. Can outdated documents make CE Marking invalid?
Yes. The Technical File and Declaration of Conformity must be kept up to date and available for inspection for at least ten years after the product was last placed on the market. If records are not maintained or are lost, your CE marking may become invalid due to non-compliance.
