Notified Bodies Explained

The compliance assessment procedure of certain products with the Europeans standards, as laid down in their corresponding EU directive, may involve the notification of third-party, independent bodies. In the EU, such organisations are called Notified Bodies and their role is to evaluate whether the product complies with the relevant legislation in force.1) In this article we will discuss the role and responsibilities of Notified Bodies.

What are the responsibilities of a Notified Body?

When a Notified Body is involved in the conformity assessment of a product, its role is to verify if the product meets the requirements. Therefore, depending on the directive, Notified Bodies can carry out one of the following tasks:

  • product certification,
  • factory production control certification, or
  • determination of the product type on the basis of type testing. 2)

First, the Notified Body assesses whether the product type is in line with the European harmonized standards set out in the legislation. If it is, the Notified Body issues an EC-type examination certificate to confirm. If the production phase conformity assessment has a positive outcome as well, the product receives an identification number. After the CE marking is completed, the manufacturer has the legal obligation to draw up a Declaration of Conformity (DoC), which guarantees on his own responsibility that the product meets the relevant European requirements and performance data. 3)

Notified Body: designated third party testing-, certification-, or inspection body.
Notified Body: designated third party testing-, certification-, or inspection body.

Who appoints a Notified Body?

Notified Bodies are designated by the Competent Authorities of each EU and EEA Member State or any other state which has concluded a Mutual Recognition Agreement and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) 4) and are notified (hence ‘notified bodies’) by the European Commission. 5) Only bodies that comply with certain criteria regarding competence and independence (typically determined by the national accreditation body can be designated and notified to the European Commission). A list of all designated Notified Bodys per Member State is provided in by the NANDO (New Approach Notified and Designated Organisations) database.6)

Is it always required to involve a Notified Body in the CE conformity assessment?

According to European legislation, the involvement of a Notified Body in the conformity assessment procedure depends on the type of product and the European harmonized standards which have to be met in each particular case. For example, in the case of medical devices which present risk factors, certification by a Notified Body is required. In other cases when a Notified Body is not required, the manufacturer has the choice to engage a Notified Body in the conformity assessment procedure for consultation. 7) More details on the categories of products that are required to notify a body can be found on the CE marking-page of the European Commission website.

How to choose a Notified Body?

A manufacturer may choose any accredited Notified Body established in any EU Member State to verify the compliance assessment. However, it is important that the decision on which body is the most appropriate takes into consideration the technical competence of the body, the product type and the needed service. In the selection process, the manufacturer should look carefully at whether the body can inspect all classes of products, as well as the specific product type that the manufacturer intends to place on the European market. In this respect, choosing a Notified Body with experience and a range of specializations can save the manufacturer considerable time and effort. This has proven particularly instrumental in the case of combination products, which have to meet the requirements of more than one directive. 8)

Where can I search for a Notified Body?

A list of Notified Bodies from each Member State can be found in the European Commission NANDO database.


1) https://en.wikipedia.org/wiki/Notified_Body

2) https://ec.europa.eu/enterprise/sectors/construction/declaration-of-performance/notified-bodies/index_en.htm

3) https://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/manufacturers/notified-body/index_en.htm

4) https://ec.europa.eu/enterprise/newapproach/nando/index.cfm

5) https://www.bsiamerica.com/en-us/Sectors-and-Services/Industry-sectors/Healthcare-and-medical-devices/CE-marking-for-medical-devices/What-is-a-notified-body/

6) https://ec.europa.eu/enterprise/newapproach/nando/index.cfm

7) https://www.mddionline.com/article/identifying-right-notified-body-entering-european-market

8) https://www.mddionline.com/article/identifying-right-notified-body-entering-european-market

4 thoughts on “Notified Bodies Explained”

    • If the product is certified by a Notified Body, typically an annual or three annual re-certification takes place. You’d pay for that. Most CE products do not need to be registered, and thus there are no annual registration fees.

      Reply
  1. Han, with regards to medical devices. I’m interested in ways to comply with the Essential Requirements (MMD) but I would like to avoid implementing the recognised standards (ISO, IEC). Is there a way to comply with the Essential Requirements without implementing the international standards? I’m a bit confused with regards to identyfing the harmonised standards. Can I find somwhere an exact instruction to follow in order to fulfill the Essential Requirements without turning into the massive procedure of ISO/IEC?

    Reply

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