Notified Body – When is it Relevant?

The term “Notified Body” is used in connection with EU regulation of certain products, including medical devices under the MDR.

For clinics and suppliers, it is important to understand when a Notified Body is involved – and when it is not.

What is a Notified Body?

A Notified Body is an independent organization approved by EU member states to assess conformity for certain types of products.

In practice, this means that:

• Some products require external assessment
• Documentation is reviewed by a third party
• Certificates can be issued after assessment

Are all CE marked products assessed by a Notified Body?

No.

Many products can be CE marked by the manufacturer's own declaration (self-declaration), depending on classification and legal basis.

Read about CE and MDR here:
https://velurex.dk/pages/ce-og-mdr

When is Notified Body relevant?

It depends on:

• Product classification
• Whether it falls under the MDR
• Risk level

For certain types of medical devices, the involvement of a Notified Body is required. For other products, it is not necessary.

Laser classification as Class 4 is about radiation safety and is not the same as MDR classification.

Read about class 4 here:
https://velurex.dk/pages/laser-klasse-4

What should clinics ask about?

When investing in clinic equipment, it may be relevant to clarify:

• What legislation does the product fall under?
• Whether a Notified Body is involved
• What documentation is available?
• Who bears regulatory responsibility

Read about purchasing laser equipment here:
https://velurex.dk/pages/koeb-laserudstyr-til-klinik

Read about imports here:
https://velurex.dk/pages/import-af-medicinal-udstyr

The role of the supplier

A professional supplier should be able to explain:

• Whether the product is covered by the MDR
• Whether the Notified Body is involved
• What documentation applies?

Read about supplier selection here:
https://velurex.dk/pages/laser-leverandoer-danmark

Contact

If you would like to discuss regulatory matters and documentation, you can contact us here:
https://velurex.dk/kontakt