Using a third party

How to find a third party

The European Commission maintains a public, online database which includes all designated notified bodies: Nando (New Approach Notified and Designated Organisations) Information System. This database contains different lists of notified bodies, including the identification number and contact details of each notified body as well as the tasks for which it has been notified.
To find a notified body, do like this:

• Click on the tab “Legislation” in the left-hand column of the webpage.
• his takes you to a list of all the directives and regulations where notified bodies can be required. Find the piece of legislation that governs your product. Click on it.
• This takes you to a list of the organisations that have been notified for that piece of legislation. The list can be sorted in different ways by clicking on the headers of the columns.
• If you click on one of the organisations, you will come to a webpage with detailed information about the organisation including in particular contact details and details about the scope of their notification area. Be aware that most of the Notified bodies only cover a limited range of the products and processes that fall under a specific directive. This can be seen from the scope of the notification. It can be found by clicking on the text “HTML” or “PDF” in the rightmost columns in the overview of legislation in the bottom of the webpage.

It is possible to filter the results to focus the search. There are two filters:

• A filter called “Procedure/Article or annex:”
  If you click on the text “ALL” in the field to the right of the name of the filter, you will see a dropdown list looking something like this example (taken from the Regulation on Personal Protective Equipment).

  

  Select the option that you need.

• A filter called “Products:”
  If you click on the text “ALL” in the field to the right of the name of the filter, you will see a dropdown list looking something like this example (again taken from the Regulation on Personal Protective Equipment).

  

  Select the product category for your product.

Remember to click the “Search” button when you have selected your filters. The two lists will vary from one directive to another depending upon how the notified body must be involved and what product groups exist for the directive.

How to work with a third party (notified body)

The relationship between a manufacturer and a notified body is as with any other laboratory a purely commercial one. The manufacturer will order the services he wants to purchase from the notified body. The manufacturer can contact more notified bodies to get more quotations and thereby obtain better prices if he wishes. It is also permitted that a manufacturer contracts more notified bodies, e.g. one notified body for the type examination and another one for the production control. All notified bodies must be established in the EU and have the required know-how there.

The type examination undertaken by a notified body is very similar to that of any other kind of laboratory except that the scope of the certification is described explicitly in the specific Directive or Regulation:

• The notified body and the manufacturer agree on the services to be provided.
• The manufacturer delivers the technical file to the notified body.
• The notified body checks the technical file and acquires missing documents from the manufacturer. When the file is complete and in compliance with the concerned Directive or Regulation, it is approved.
• The manufacturer supplies a number of samples of the product for testing and/or provides the notified body with the documentation of its quality assurance system.
• The notified body tests the product, and/or checks the quality assurance system of the manufacturer and/or pays visits to manufacturer’s premises. This may initiate a number of iterations if the product doesn’t comply so the manufacturer can improve his product and/or its quality assurance system.
• When the tests show that the product is in compliance, the laboratory will issue the EC type certificate on the specific design of product which meets the regulatory requirements.

If the legislation also requires that a notified body is involved in the production control, this can be organised independently from the type certification process and at any suitable time.

Guidance material

General guidance on using a third party:

• The ‘Blue Guide‘ on the implementation of EU product rules 2020

Related topics

In order for manufacturers to ensure they produce only safe products, there are a range of processes to follow and documentation to be developed. As these apply to many types of products generally, there are a number of Fact sheets which cover these. Please refer to respective sections of the SPEAC FINDER regarding:

• CE marking
• Conformity assessment
• Declaration of conformity
• EU consumer protection
• EU market surveillance
• Product safety checklist
• Recall procedures
• Risk management
• Safety Gate / RAPEX
• Selling online
• Technical file
• Testing

You may also visit the SPEAC ACADEMY to learn more about the EU Safety requirements.