Using NANDO to Evaluate Notified Body Designation Scope

What NANDO is actually for

Most manufacturers know that Notified Bodies have to be designated under MDR before they can issue certificates. What fewer teams act on is that designation is not generic — every NB is designated for a defined set of device types, classifications, and annexes. NANDO (New Approach Notified and Designated Organisations) is the European Commission's public database that publishes that scope in detail. Before you approach an NB, before you ask for a quote, before you sign anything, check NANDO.

The practical consequence of getting this wrong is that you can invest months in pre-submission dialogue with an NB only to find they cannot certify your device. Some NBs will tell you upfront; others will get further into the process before the scope mismatch becomes a problem. Using NANDO early avoids both scenarios.

How to read a designation entry

When you search for a Notified Body in NANDO, the entry shows the Regulation (MDR 2017/745 or IVDR 2017/746), the NB's identification number, and — critically — its designation scope. The scope is expressed in terms of MDR Annex references (Annex IX, X, XI) and device categories.

Device categories in NANDO follow MDR's own classification structure, but they are presented as numeric codes. MDCG 2019-6 provides the reference table mapping these codes to device types. The step most teams miss: you need to check whether the NB's scope includes both the right device category AND the right conformity assessment annex for your route. An NB may be designated for Annex IX but not Annex X for your device type — which matters if your device requires type examination.

One thing that catches teams off guard: "designated" does not mean "actively taking new clients." Designation scope tells you what an NB is legally permitted to certify. Their actual capacity, waiting list, and commercial appetite are separate questions you can only get from the NB directly.

Designation scope vs. device type — where mismatches happen

The most common scope mismatch involves devices that sit at category boundaries. Software as a Medical Device (SaMD), combination devices, and devices with an ancillary medicinal substance are areas where NB designation scope is frequently narrower than manufacturers assume.

For SaMD: not all NBs are designated for software. Check specifically for Rule 11 and the relevant device categories. For combination devices with an integral medicinal substance: the NB also needs a consultee relationship with a Competent Authority or the EMA for the medicinal part — this is a separate check beyond the standard NANDO designation scope. If your device has any of these characteristics, the NANDO check is more involved than just confirming the device class.

Sterile devices and devices with a measuring function at Class I require partial NB involvement — an NB needs designation specifically covering those aspects. This is often missed by teams whose Class I device falls into one of these sub-categories for the first time.

Practical timelines and what NANDO tells you about them

NANDO does not publish timelines. What it does tell you is how many NBs are designated for your device type — which is a proxy for how much choice and therefore leverage you have. For some device categories, only a handful of NBs hold the right designation. That concentration means less competition for NB business, longer wait times, and less flexibility on audit scheduling.

Once you have identified the NBs with the right scope, use their public pages or contact them directly to understand indicative timelines. Under MDR, initial certification timelines for Class IIb and III devices commonly run to 18–24 months from first contact, though this varies significantly. Building this into your project plan before you have a contract in place is not premature — it is the realistic posture.

What to do with this information

Your NANDO evaluation should produce a shortlist of NBs with confirmed designation scope for your device type, classification, and conformity assessment route. From that shortlist, you then assess capacity, timeline, fee structure, language, and the NB's track record with similar devices. Those are commercial and relationship questions. NANDO answers the eligibility question — and it has to come first.

If you find that only one or two NBs hold the right designation for your device, that is important project risk information. Document it. It affects your timeline and your contingency planning if your preferred NB cannot take you on.