Contrary to the popular opinion that CE means Conformity Europe, it doesn’t actually stand for anything. What it represents, however, is a different matter altogether. Any item that bears the CE mark meets the requirements of an appropriate European Directive and therefore has the right to freedom of movement within the EU. Simply put, a CE mark could be described as the “passport” for a product within the EU.
How do I CE mark a product?
Manufacturers play a crucial role in ensuring that products placed on the Single Market are safe. They are responsible for checking that their products meet EU requirements and ultimately affixing the CE marking to a product. Only then can it be traded on the EEA market. Here are the six steps required to gain a CE marking:
- Identify the appropriate directive(s) and standards
- Verify any requirements that are specific to your product
- Identify whether you can self-certify or if notified body* involvement is required
- Test the product to check it fulfills any requirements
- Draw up the required technical documentation and make it available
- Apply the CE marking and issue an EU Declaration of Conformity
*Some products will require the involvement of a notified body. Items such as gas boilers and chainsaws pose a higher safety risk, and so cannot be checked by the manufacturer alone. In these cases, an independent organisation, specifically a notified body appointed by national authorities, has to perform the safety check. This is also why some CE markings have a number after them, representing the notified body involved in the certification.
Step 1 – Identify the appropriate directives and standards
There are thousands of standards that apply to a vast range of products across all industries. Find the standards that apply to your product can be a major task but one that is crucial to making sure it is compliant. Harmonised Standards are European standards that have been developed by the European Standards Organisation. These standards details all of the technical requirements for products within specified categories.
You can begin your search by looking on the EU Harmonised Standards website. This is a great place to start.
Step 2 – Verify any requirements that are specific to your product
Based on your research you will need to pinpoint the exact requirements that are relevant to the product you are developing. While scoping out the product these will need to be listed to ensure that the design process factors everything in from the outset. For instance, if safety features, sensors or fail-safe devices need to be implemented, then this will need to be known and understood by the development team.
Step 3 – Identify whether you can self-certify or if notified body* involvement is required
In many cases self-certification is possible. This means that as a manufacturer you are putting your stamp on a product declaring it fit for purpose. However, in many situations you will need third-party involvement to deem the product safe for distribution. This is especially important for medical products where the design process needs to meet the requirements set out by ISO 13485.
Step 4 – Test the product to check it fulfills any requirements
Testing products and checking for their conformity relies on you as the manufacturer. This is why in many cases manufacturers will go with the self-certification route. As part of this procedure you will need to carry out a risk assessment based on the standards that apply to your product. With this assessment you will be able to test your product and ensure that each requirement is met and that as a manufacture you are satisfied with the results.
Step 5 – Draw up the required technical documentation and make it available
Technical documentation must be produced that outlines the risk assessment drawn up and evidence of the product meeting the necessary requirements. These documents must be available upon request to relevant authorities such as the EC Declaration of Conformity.
Step 6 – Apply the CE marking and issue an EU Declaration of Conformity
The CE marking on your product must be easily accessible and meet the minimum requirements set up by the European Commission. If your device is particularly small (i.e. the CE mark won’t fit) then these requirements can be overlooked.
- Must meet minimum size requirements (unless product size negates this).
- Must be easily accessible / visible.
- Must legible. Appropriate colours and contrast used.
- Must be indelible – be unable to remove easily with leaving a trace
- Can be fixed solely to the packaging where it is impossible to do so on the product.
‘The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents’ – As stated by the European Commission
How do I CE mark a medical device?
Due to a 4 tier classification system and increased N.B involvement, CE marking medical devices can be slightly more complicated.
Class I: The first class of devices is regarded as low risk. This includes standard items such as walking sticks, wheelchairs, and spectacles, but also sterile, measuring, and reusable instruments. Notified body involvement is not required for most devices in this class but for anything that measures or anything sterile, they will ensure measurements are accurate and the sterilisation process is appropriate.
Class IIa: For low to medium risk items such as dental crowns or contact lenses, manufacturers will be looking at certifying for Class IIa devices.
Class IIb: Medium to high-risk items such as dental implants or contact lens cleaning solution would then come under Class IIb and require further levels of scrutiny.
For Class IIa & 11b, notified bodies will now need to review the technical file to confirm the device meets the requirements of the directive as well as undertaking periodic reviews and quality system audits.
Class III: Devices such as pacemakers and joint implants are considered as high risk and therefore require more input from a notified body. Not only will they undergo Class II testing, but they will review and approve/decline the design dossier for the device. As with Class II devices, the manufacturer will also be subject to audits both on the quality system and the technical documentation.
Conclusion
Obtaining a CE mark for a product is a process led primarily by the manufacturer but, despite it being their responsibility, a strong design and development team can offer great support. Thorough testing ensures compliance with standards and regulations, while comprehensive technical documentation is crucial for demonstrating conformity. Understanding and adhering to the six steps laid out above will allow you to navigate the complex regulatory landscape and ensure the safety and compliance of your product in the European market.
If you are interested in developing a product then get in touch.