The role of notified bodies

Developing a medical device? That's exactly what you have to do: choose a Notified Body.

And many people are wondering: How does it work? Which one to choose? And above all... how can you avoid unpleasant surprises?

What is their role?

A Notified Body (NB) is an independent organization, designated by a Member State, and authorized to assess whether your DM complies with European regulations.

Depending on the class of your product, its intervention may concern :

• your quality management system (ISO 13485),
• your clinical assessment,
• your technical file,
• and above all: CE marking**.

Without their green light, you won't be able to market your product.

They're few... and overwhelmed

Today, only 50 NB are designated under the MDR. Some are specialized, others not.

Many are saturated. Delays can range from 6 months to 2 years.

The choice of a NB is therefore strategic, to be anticipated right from the start of the project.

How do you choose your notified body?

Here are a few key criteria:

1. MDR field of accreditation: Is it notified for your type of product? Check directly on the NANDO database.
2. Industry experience: Has it already assessed similar devices?
3. Working language: Some NBs require 100% English, including for audits.
4. Estimated timeframe: Anticipate, some don't take on new customers any more.
5. Quality of communication: Choose those who communicate transparently and responsively.

How much does it cost?

The cost depends on several factors:

• the risk class of the device,
• the complexity of the device and the technical file,
• the size of the company, and
• the number of non-conformities to be dealt with, and the series of examinations required.

NBs generally provide an indicative price grid, which gives a more or less precise idea of the cost.

How do you approach them?

• Prepare a clear summary of your product (medical purpose, risk class, state of progress, expected date of submission of the technical file).
• Fill in their introduction form.
• Contact several NBs in parallel to compare.
• Take care of your file: clarity = credibility.

And remember: you choose them, not the other way around.

Certeafiles helps you manage this critical step

We help MD manufacturers to :

• Identify NBs compatible with their strategy
• Prepare the first exchanges and the required documentation
• Clarify expectations for a solid and admissible dossier.
• Anticipate schedules and avoid delays

➡️ Less back and forth, more peace of mind.

Do you have a question? Need support or training?

Write to us at contact@certeafiles.io or through our contact form.