Choosing a notified body under the MDR

Under the MDR, you choose a notified body based on three things: whether the body is designated for exactly your type of device, whether it has capacity within your planning, and how many hours it estimates for your file. Only after that do you look at the hourly rate. A notified body is an organisation designated by the government to assess whether your device complies with the EU MDR 2017/745 .

You need a notified body for every MDR risk class above class I, and for class I products that are sterile, have a measuring function or are reusable surgical instruments. You can check whether a body is designated in the European database NANDO . Read the difference between a notified body and an ordinary certification body on MDR and ISO 13485.

You may choose any notified body in the EU, not only a Dutch one. A certificate from a notified body applies across the whole EU.

Which notified bodies are in the Netherlands?

According to the Inspectie Gezondheidszorg en Jeugd (IGJ, Health and Youth Care Inspectorate) , four notified bodies are designated in the Netherlands for medical devices:

Notified body	Note
BSI Group The Netherlands B.V.	Part of the British BSI
DEKRA Certification B.V.	Part of the German DEKRA
Kiwa Dare B.V.	Part of Kiwa
Scarlet NB B.V.	Newer body

The Minister of Health, Welfare and Sport (VWS) designates Dutch notified bodies. The IGJ supervises them through inspections, file checks and attending audits. A re-assessment takes place every five years. Which product types a body may assess differs. Always check this in NANDO.

How do you check a notified body in NANDO?

NANDO is the official list of the European Commission. A notified body’s website may be out of date; NANDO is not.

Search by legislation

In NANDO, choose the legislation “Regulation (EU) 2017/745 on medical devices”. The old directive no longer applies to new applications.

Open the notified body

You see its four-digit number, its country and the status of its designation. That number later appears next to the CE marking on your product.

Check the scope codes

Each designation has codes per product type and technology. A body that may only assess non-active devices cannot certify your software. Put the codes for your own product next to them.

Check the conformity routes

Check whether the body may apply the annex that belongs to your class, for example Annex IX for assessment of the quality system and technical documentation.

What do you compare notified bodies on?

After the NANDO check, a few bodies often remain. Compare them on these points. The order is deliberate: capacity and experience weigh more than price.

Criterion	Question to ask	Why it matters
Scope	Do the designated codes fully cover my product, including future variants?	Otherwise you have to find a second body later
Capacity	When can the first audit take place, and when do you expect a decision?	Waiting times sometimes run to months
Experience	How many comparable products have you assessed?	Experienced assessors ask more targeted questions
Hour estimate	How many hours do you charge for document assessment and audits?	This determines the price more than the hourly rate
Rates	What is in your public rate list?	Publication is mandatory under Article 50 MDR
Language	May my documentation be in Dutch or English?	Translation costs time and money
Combination	Can you also certify ISO 13485 in the same audit?	Saves audit days
Dialogue	May I ask questions about the approach in advance?	Prevents surprises during the assessment

For what these hours and rates mean in practice, see MDR costs.

Example: comparing quotes for a software product

A Dutch start-up makes decision-support software in class IIa. It requests three quotes.

	Body A	Body B	Body C
Software scope in NANDO	Yes	Yes	No
First audit possible	In 9 months	In 4 months	Not applicable
Estimated hours for document assessment	30	55
Hourly rate for document assessment	€450	€380
Cost of document assessment	€13,500	€20,900

Body C is ruled out on scope. Body A is more expensive per hour, but cheaper overall. Body B can start five months earlier. For this start-up, market access outweighs the €7,400 difference, so it chooses B. The amounts in this example are fictional.

What does a notified body need for a quote?

A notified body can only make a realistic hour estimate if you describe your product well. The more complete your request, the more reliable the quote. Prepare these details:

Detail	Why the notified body asks
Intended use and class	Determines the conformity route
Number of products and variants	Determines how much technical documentation is assessed
Technology, such as software, sterile, implant	Determines the scope codes and the specialists needed
Number of sites and employees	Determines the number of audit days
Important suppliers	Critical suppliers may also receive an audit
Status of ISO 13485	An existing certificate can shorten the audit
Desired planning	Shows whether the waiting time fits

What happens after you choose?

You sign a written agreement with the notified body. Then follows the audit of your quality system and the assessment of your technical documentation. If all goes well, you receive a certificate valid for up to five years. The notified body enters that certificate in EUDAMED, see UDI and EUDAMED registration.

The notified body also returns after certification: every year for an audit, and at least once every five years unannounced.

Can you change notified body?

Yes, Article 58 of the MDR regulates a voluntary change. In an agreement with the old and the new body, you record when the old certificate stops, who is responsible for the assessment and how the number on your label changes. Switching costs time and money, so it pays to choose well from the start.

Common mistakes when choosing a notified body

Choosing on the hourly rate alone. The number of hours and the waiting time determine the real cost.
Not checking scope in NANDO. A body can be designated under the MDR but not for your technology.
Approaching bodies too late. Start the conversations while your design is still in progress, not when your file is finished.
Submitting an incomplete file. This leads to extra rounds and sometimes to a rejection.
Confusing a notified body with a certification body. For ISO 13485 alone, you can also choose a body without an MDR designation. See choosing a certification body.