One of the most frequently asked questions by manufacturers seeking CE certification is:
«Which tests do I need for my product?»
The answer to this question varies depending on the product’s technical specifications and the European Union (EU) regulations it falls under. In this article, we provide an overview of the essential tests you may encounter during the CE Marking process, categorized by product types.
The CE mark indicates that a product meets the safety, health, environmental, and performance criteria set by the EU. This compliance is often validated through specific CE tests.
These tests help to:
Relevant regulations:
Required tests:
Relevant regulation: Machinery Directive (2006/42/EC)
Required tests/analyses:
Relevant regulation: Toy Safety Directive (2009/48/EC)
Required tests:
Relevant regulation: MDR 2017/745
Required tests:
Note: The Notified Body process is mandatory for medical devices.
Relevant regulations:
Required tests:
Relevant regulation: PPE Regulation (EU 2016/425)
Required tests:
Note: For Category III PPE products, the Notified Body evaluation is mandatory.
Relevant regulation: Construction Products Regulation (EU 305/2011)
Required tests:
Not all products require tests. In some cases, the process can be completed with just a technical file and a declaration of conformity. However, tests are almost always mandatory in the following cases:
Knowing which CE tests are required for your product enables you to manage the process both faster and more accurately. Identifying the correct standards from the beginning is crucial to avoid unnecessary costs and ensure full compliance with regulations.
If you want to know which tests are required for your product and plan your CE certification process, feel free to contact Sertifike.
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