How Long Does CE Certification Take?
This is like asking “how long is a piece of string?”. Let us explain…
While the CE certification process is straightforward, the intention should be “do it right, do it once”. Redesigns and retests all consume valuable resources in both time and money which could be used elsewhere. It’s better to carefully execute all steps in the process instead of rushing and needing to take steps backward later.
If we use the five-stage CE certification process for a simple product, you can expect stages 1-4 to take no longer than two months. For a complex product, it could be three or four months.
These timescales also assume everything checks out the first time through. Any failures or repeats will increase the time and costs so preparation is key.
Let’s look at each of the five stages in detail.
Stage 1: Legislation Identification
It would not be wise to overlook the importance of starting the process correctly and early in the product design cycle. Normally, reviewing the Directives and Regulations is a short step. The specifications of the product are reviewed against the relevant CE Marking directives.
Where this can be problematic is if the product has novel features. You may have to determine which directives apply and navigate when the product falls between two directives.
If you are unfamiliar with EU legislation, Technology International can give you a competitive advantage, by shortening the time to identify the correct and appropriate legislation.
Stage 2: Product Compliance
In the majority of cases, the self-assessment route is chosen, frequently using Harmonised Standards, as the standards generally address the hazards and characteristics of the products. This stage is best performed in conjunction with the product design and development as any changes are more practical and cost-efficient to implement at that stage.
Don’t make the mistake of not considering the standards until the product is designed and almost ready to be launched. Post-design changes are always expensive. Include your suppliers in this activity.
Technology International can offer invaluable assistance, ensuring that all product aspects are covered in selecting the compliance route.
For some products, a Notified Body must be used. Talk to Technology International to determine if this applies to your product, and how nest to proceed.
Stage 3: Technical Documentation
This stage is where the product is tested, and if required, changes are made to show it complies with the law.
If you use a 3rd party inspection body or test lab to help you assess your product, how quickly and completely you respond to their requests for information, especially documentation, will directly impact how long they take to do their work.
Retests delay the process. Apart from the corrective actions, there are all the associated costs and delays in having the product retested. That’s why doing it right the first time should be your goal – and this is where Technology International’s proactive approach stands out.
Instructions and manuals are important as they have to include safety and other warnings. In addition, they must always be translated into an official language of the destination country.
The Technical File is then put together showing conformity to the essential requirements of the applicable Directives and Regulations.
The last phase is to produce and sign the EU Declaration of Conformity or DoC. This is the legally binding document showing the products’ compliance. It is used by Customs, as well as by end-users. An incorrect DoC can cause Customs delays to your shipped products.
Stage 4: Apply CE Marking
This is a short process but the CE Marking needs to be a certain size, be indelible, visible, and legible. Normally this is the last stage on the production line when the product is ready for its final inspection prior to shipping.
Stage 5: Ensure Ongoing Compliance
This is the longest phase as it takes the working life of the product into account for up to 10 years, as well as new production. All the new products need to comply with the requirements so a manufacturer ideally should have a QMS system in place covering these minimal aspects:
- Inspection of incoming parts
- Production line tests
- Change control process with appropriate authority for change
- Final product tests before shipping
- Feedback from the field process
- Sample checking
- Handling and selection of critical components
- Regular review of changes to the legislative requirements
- Regular review of changes to the Harmonised Standards
- Regular product compliance review
Reduce CE Certification Setbacks With Technology International
Due to the nature of the CE certification process, it is difficult to give a firm and fast time summary. By choosing to partner with Technology International, you are getting a competitive edge concerning time through the careful preparation and guidance of our team. We’ll help you get your product(s) to market in the shortest time possible.