Notified bodies play a central role in the CE certification process. Notified bodies perform precise, hands-on evaluation of products seeking the CE mark, an incredibly important step in the certification process for many products.
In this way, notified bodies affect hundreds
of millions of people—they evaluate and approve the products that end up on
store shelves, in medical offices, and on industrial sites throughout the EU
and other countries that have adopted EU standards.
What is a Notified Body?
A notified body is an organization that is authorized to assess conformity and compliance of a product before it enters the European Union (EU) market. When a manufacturer wants to enter the EU market and needs CE certification to do so, the notified body is the one responsible for evaluating the product and verifying that it performs up to the specifications of the relevant standard(s).
The notified body exists to identify the right standards and evaluate products according to those standards—but there are also standards that govern the designation and approval of the notified bodies themselves. Notified bodies are evaluated, approved, and monitored by EU countries according to the standards described in EN ISO/IEC 17000.
The EU market includes EU countries, European
Free Trade Association (EFTA) countries like Iceland and Norway, and additional
that have adopted Mutual Recognition Agreements (MRAs) with the EU. When a
notified body is approved by one of these countries to perform conformity
assessments, it will be notified—hence the term notified bodies—and listed in the European Commission’s notified bodies database.
What Role Do Notified Bodies Play in CE Certification?
For certain types of products that present a risk of injury to consumers, like medical devices, working with a notified body is mandatory. The manufacturer must review the list of accredited notified bodies and choose one to verify the compliance assessment. The decision of which notified body to use is up to the manufacturer, but it is important to choose a notified body that makes sense for the type of product and the technical competence required to evaluate the product. For example, it is beneficial to work with a notified body that can conduct a wide range of tests if the manufacturer is seeking CE certification for multiple products or for a product that involves a combination of functions, standards, and/or tests.
However, working with a notified body is not
always mandatory. CE marking is a self-certification process that only requires
working with a notified body for certain types of products. Certain products,
according to European harmonized standards, do not require the involvement of a
notified body—but the manufacturer still has the choice to engage a notified
body to ensure they are applying the correct standard(s) and/or testing their
product to the correct specifications.
Contact G&M Compliance to Discuss CE Certification
To successfully complete the CE certification
process, it’s important to understand what standards apply to your product and
whether a notified body is mandatory in your situation. A compliance expert
like G&M Compliance can help you pinpoint the relevant standards, create a
cost-effective and long-term compliance strategy, and help you choose a
notified body to work with.
Contact G&M Compliance today to learn more
about the requirements of the CE Mark and how to work with notified bodies.