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A Hardware Startup’s Path to Getting a CE Mark

Getting a CE mark is a big step for any hardware startup. But what is a CE mark? Why is it so important? And what did we do to get certification for our predictive maintenance sensors?

The CE mark: what it is and why it’s important

The CE mark is a fundamental certification for hardware startups. The mark has existed in its current form since 1993. CE stands for “Conformité Européenne”. As such, it means that products with the mark comply with European directives. The mark is mandatory to enter the European market, both for products that are produced within the EEA and for products coming from external markets.

Certifying the conformity of a product to European standards has two main purposes: facilitating the trading of goods inside of the EEA, and ensuring the harmonization of laws concerning safety, health, and environment.

How to become CE certified

The responsibility of affixing the CE mark can fall to the manufacturer or the importer—in general, the person who is trying to place the product on the European Market. The steps to get certified are as follows:

  1. Identify the applicable directive(s) and harmonised standards

Directives concern basic requirements for safety and health. Harmonized standards are given by the European Commission and concern the more technical aspects of the product. When a product conforms to the harmonized standards, then it also conforms to the directives’ safety and health rules. One product can be subject to more than one directive. This also means that if a product doesn’t fall under the scope of any directive, it will not be required to show the CE mark. Directives can also contain different standards, and they usually vary according to the type of product (chemicals, cosmetics, radio equipment, medical devices etc.). A complete list of directives can be found here.

In our case, our research showed that our condition monitoring system is identified as Radio Equipment, which is disciplined by the RED (Radio Equipment Directive). However, the RED also refers to other directives (eg. Low Voltage and EMC). In turn, each of these directives contain a great number of standards. It is necessary to find out which standards are actually required for a specific product to be CE certified.

2.  Identify whether an independent conformity assessment (by a notified body) is necessary

For some products, it is necessary that a third party, a notified body, also validates the test. This step is common for products that directly concern health and safety (eg. medical devices such as pressure vessels etc.). In this case, the CE mark will be followed by the registration number of the notified body involved in conformity assessment.

3.  Test the product and check its conformity

Testing can be carried out in many different facilities. The choice of the exact laboratory is based on the criteria that suit the manufacturer and the applicable directives and standards.

When it comes to getting certified, some directives only concern the objective characteristics that the components should have. Other requirements are related to the performance of the product under particular conditions. This is why, to certify our predictive maintenance sensor, Aion, our team decided to first carry out pre-compliance tests.  Pre-compliance tests are not mandatory. But since they require less documentation, they give the manufacturer the chance to check the performance of the product and see if any further iterations are required before attempting the actual CE tests. After passing all the Pre-compliance tests, we carried out the CE test with great confidence.

4.  Draw up and keep available the required technical documentation

The production of technical documentation happens throughout the whole process. Some documentation has to be presented at the testing facilities. At the same time, the results and reports produced during the testing will also become part of the documentation. That usually includes all technical content about the product, ranging from user manuals and materials’ certificates to test reports and results. Keeping all documentation available and current is a must. When a notified body is not involved, the manufacturer is 100% responsible for the documentation and, therefore, for confirming the validity of the CE mark.

5.  Affix the CE marking and draw up the EU Declaration of Conformity

After the CE Mark has been achieved, it can be affixed to your product. You can then complete the Declaration of Conformity (DoC). This final, mandatory document has to be signed by the manufacturer (or responsible person) to certify that the product complies with all applicable directives and standards.

6.  Celebrate!

Achieving the CE certification can be a long and tedious process. You and your team deserve a good celebration when it’s over!

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