Notified Body Selection and Application

Notified Bodies are conformity assessment bodies in the European Union. The EU Member State authority designates a notified body, which is a third party assessing the safety and conformity of certain products before they are sold in the EU Member States.

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The Representative of choice for

For some products, manufacturers can ensure conformity through a self-declaration without the involvement of a third party. For other products, the conformity must be assessed by a notified body. Depending on the type, products which require a notified body’s assessment are for ex. higher risk medical devices & IVD medical devices, lifts, personal protective equipment, pressure equipment, and machinery, among others.

However, when a self-declaration is sufficient, manufacturers still have the option to let a notified body assess their product.

The list of notified bodies is publicly available on the NANDO website of the European Commission. Notified Bodies might only assess some types of devices under a specific legislation (designation scope), even if they have been designated under that particular legislation. For instance, notified bodies assessing medical devices might not assess medical devices from all risk classes.

For some products, the conformity assessment procedure might be shorter and finding a notified body could be relatively easy. For some other products, the scenario is different. With the latest changes in the regulatory world of medical devices, Notified bodies are facing a very high demand beyond their capabilities. Thus, finding a notified body can be challenging and waiting lists could be long.

With knowledge and network in the field, Obelis helps manufacturers to find the right notified body. We contact different notified bodies, provide them with the necessary information on your products (Notified Body Selection), and – when the manufacturer wishes – we apply on behalf of the manufacturer (Notified Body Application).

Especially for manufacturers of medical devices and IVD medical devices, it is crucial to find a notified body as soon as possible. Under MDR, the EU grants manufacturers an extension of the grace period only when the manufacturer has already taken concrete steps towards an MDR certificate. This includes applying for a conformity assessment by May 26, 2024, and having a signed agreement with the Notified Body 4 months later – by September 26, 2024.

We advise not to delay and miss the crucial deadline of May 26, 2024!

Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.