How to Select a Notified Body (NB) for CE Marking

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Many medical device’s manufacturers have difficulties in locating a notified body for CE Marking of their products. This article provides detailed information on the notified body selection criteria which could be implemented by manufacturers who are planning to put their medical devices on the EU market.

Still with 30 NBs for MDR and 12 NBs for IVDR, the medical device manufacturers have serious concerns as to whether the number will be sufficient for the implementation till the end of transition period (For Class III and IIb implantable medical devices 31 December 2027 and for Class IIb, Class IIa and I 31 December 2028).

The fact is that although the number of designated NB is 30 for MDR and 12 NBs for IVDR, not all of them have been designated for the full scope. Therefore, many manufacturers with specific type of medical device, cannot get reasonable quotations for MDR transition. The situation for manufacturers like start-ups looking for initial certification and the ones located outside EU is even worse. Naturally with limited resources the NBs are trying to plan the transition for their existing clients.

Before making an application to a Notified Body, you have to ensure that Notified Body is designated for your medical device.

Let’s first start with the definition of what a notified body means.

A Notified Body is an authorised organization designated by a European Commission to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required. The European Commission publishes a list of such notified bodies on Nando Web Page https://ec.europa.eu/growth/tools-databases/nando/.

Before selecting the right Notified Body, manufacturers can access the list of notified bodies by choosing one of the country, legislation and body options from the Nando web page. The full scope of notification of the Bodies (also called “scope of the designation”) to the different Directives or Regulation can be found on the NANDO website which is regularly updated (either for new notifications, an extension of the scope of notification, suspension or termination of some bodies).

Each Notified Body is identified by four-digit numbers on the NANDO website. For medical devices requiring to be reviewed by a Notified Body, the CE-mark symbol on documents (and on the devices themselves) will be followed by the four-digit numbers corresponding to the Notified Body which conducted the review and issued the CE certificate.

The scope in which notified bodies are authorized may differ. You must select the relevant legislation on the Nando page so that you can determine which notified body is in the jurisdiction of your products. After you have selected the relevant legislation, you will see a list of all Notified bodies in the relevant regulation. Here you can access the scopes and related codes for which they are authorized by clicking on the notified bodies. Then, you can check which code your product covered.

When a manufacturer applies to the notified body, the type of devices and technologies shall be specified subject to conformity assessment activities. In order to determine which code is suitable for your product, you need to pay attention to the following points:

Explanation of MDR codes to devices within the conformity assessment procedure

MDR Codes are divided into 3 groups:

  • MDA / MDN: Codes reflect design and intended purpose of device.
  • MDS: Horizontal codes that reflect the specific characteristics of the device.
  • MDT: Horizontal codes that describe technologies or processes that are used in the manufacturing and making available of the devices.

You can find the detailed information regarding these codes and examples on MDR MDCG 2019-14 Guidance Document.

Explanation of IVDR codes to devices within the conformity assessment procedure

IVDR Codes divided into 5 groups.

  • IVR: Codes reflect the design and intended purpose of the device.
  • IVS: Horizontal codes that reflect the specific characteristics of the device
  • IVT: Horizontal codes that describe technologies.
  • IVP: Horizontal codes that describe knowledge in examination procedures.
  • IVD: Horizontal codes that describe knowledge in laboratory and clinical disciplines.

You can find the detailed information and examples regarding these codes on MDCG 2021-14 Guidance Document.

If you have difficulties on selecting the right MDR or IVDR codes and NBs, you can contact us. Medloft experts will be very happy to help you.