Notified Body Selection and Negotiation
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.
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 present an overview of offers and timetables (Notified Body Negotiation).
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!
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”