What is a Notified Body?

When our customers are working on exporting products to Europe, a common question is “What is a Notified Body?”  Similar to the U.S. system for registered Certification Bodies, Notified Bodies are accredited by a given European Union member state to certify that a product meets a particular Directive and Standards.  Let’s take a look at what that means.

Under the New Approach for using standardization to support legislative mandates of the Directives system, the need for certification of certain critical products was apparent.  While it was deemed appropriate for any number of imports and domestic goods to be self-certified, there are some things that have a significant impact on public health and safety.  The Harmonized Standards system of the New Approach is complemented by the certification program of the Notified Bodies.

Since as yet there is no “United States of Europe,” the member states of the EU still have an essential role to play in many enforcement activities.  So when it comes to insuring that goods covered by such directives as the Medical Device Directive and the like, each member state can authorize one or more certification organizations to review the specifics of product conformance to various New Approach legislation.

When you have a product that’s covered by a Directive that has a Harmonized List of Standards, one way to import that product into the European Union is to have it certified by a Notified Body or it’s affiliates.  This allows for the use of the CE mark which you’ll include along with the appropriate paperwork when your product is transported into the EU jurisdiction.

What companies are Notified Bodies?  There’s quite a list of them!  One easy way to check this out is to go to the NANDO database.  Here you can locate any of the currently authorized certification organizations, along with those organizations outside the EU that are authorized by way of MRA’s (Mutual Recognition Agreements).

One important aspect of the New Approach, the Harmonized Standards, and their Directives, is that meeting the requirements of specific Harmonized EN Standards can allow for what’s called the “Presumption of Conformity.”  This means that by using standards on the Harmonized List of Standards for specific Directives, you can meet specific clauses in that Directive itself.

To learn more about the standards that can support your products and the sale of your goods in Europe, contact Document Center Inc.  EN standards can all be purchased at our web store, www.document-center.com.  These standards are all provided under license agreement with the source organization per copyright requirements.  And if you have any additional questions, please don’t hesitate to get in touch with our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!