Determining the need for a Notified Body
After identifying all CE directives and standards necessary for your product’s CE compliance, you need to determine if you have to go through a third-party assessment. Each EU directive will state whether you need a third-party evaluation or not, but note that not all CE directives require it. In this regard, it’s essential that you know what the applicable CE directives demand. When you don’t need it, you can assess the CE conformity of your product relying on your in-house facilities. In all other cases, the assessment is performed by conformity assessment bodies, also known in Europe as notified bodies.
A notified body is an organisation designated by an EU country to assess the CE conformity of specific products. These bodies carry out tasks related to conformity assessment. For instance, a review of the technical file and test reports. The notified bodies also perform an audit to verify the manufacturer has correctly completed the first steps, i.e., identifying the correct directives and essential requirements.
Directives indicating the need of a notified body are Medical Device directive; Simple Pressure Vessels directive, Pressure Equipment directive, Equipment and Protective Systems in Potentially Explosive Atmospheres directive, and Appliances Burning Gaseous Fuels directive. However, note that some other CE directives may not require the use of a notified body if you follow the Harmonised standards. For instance, the Machinery Directive and the Toy Safety Directive.
Product’s CE Compliance Assessment
To know that your product complies with the respective requirements in the applicable directives, you need to test and document it. In each CE directive, you can find all CE compliance assessment procedures (modules), you need to undertake. The conformity assessment modules are 8 (see the table below), but one or more of them can apply for your particular product. If your product gets closer to module H, then the notified body becomes more important.
|Internal production control|
EC type examination
Conformity to type
Production quality assurance
Product quality assurance
Full quality assurance (EN ISO 9001)
The CE compliance assessment consists of many activities, among which visual inspection, product testing, risk analysis and review of product’s labels and instructions. To conduct a risk analysis of your product, you should be able to answer the following questions:
- What hazards is the product associated with?
- Are there any risks to people, animals, other goods or the environment?
- What solutions can be applied to minimise risks according to current EU directives?
It’s important to know that you, as a manufacturer, could choose among the different CE compliance assessment modules, as long as the applicable CE directive allows it. Knowing that could help you save a lot of time and money.