EU notification system · legal scope · notified-body identity
What is NANDO?
The list is public. The difficult part is knowing what the listing actually means.
NANDO is the EU’s permission map for notified bodies. It can confirm who is legally designated, under which legislation and for which scope. It cannot tell you who wants your project, has capacity next month or is the best technical match.
The database behind the four digits
NANDO is a legal register, not a matchmaking service
A notified-body number can look like a universal licence. It is not. The number identifies the organisation; the published scope defines what that organisation is authorised to assess.
NANDO gives the regulatory answer. Choosing a workable certification partner requires a second layer of due diligence.
01
NANDO in one sentence #
NANDO stands for New Approach Notified and Designated Organisations. It is the European Commission’s public information system for bodies notified under EU product legislation.
For medical devices, it lets a manufacturer check bodies designated under Regulation (EU) 2017/745. For in vitro diagnostic medical devices, it provides the corresponding list under Regulation (EU) 2017/746.
The organisation, country, contact details and four-digit notified-body number
The directive or regulation under which the body has been notified
The conformity assessment activities and types of devices the body may assess
The four-digit number is the passport number. The designation scope is the visa. You need both before the journey can begin.
02
A body does not simply add itself to the list #
A candidate starts as a conformity assessment body. The responsible national authority assesses its organisation, quality management, resources, processes, independence and technical competence, with European experts involved in the joint-assessment process.
The Member State designates and notifies the body. The Commission publishes the notification in NANDO. Under the MDR, the designation becomes valid on the day after publication, and the published notification states the scope of lawful conformity assessment activity.
The conformity assessment body defines the legislation, device types and activities it seeks.
Authorities and European experts examine compliance, competence, resources and processes.
The responsible Member State decides which scope the body is authorised to cover.
The Member State submits the notification through the Commission’s electronic system.
NANDO makes the valid notification, identity number and lawful scope publicly visible.
National authorities continue monitoring notified bodies, including annual assessment activity and periodic complete reassessment under the MDR.
03
A NANDO record has four regulatory layers #
Reading only the organisation name is like reading only the title page of a technical file. The useful information sits several layers deeper.
Legal name, address, country, contact information and identification number
MDR, IVDR or another EU legal act under which the notification was made
The assessment procedures the body is authorised to perform under that legislation
The designation codes and any conditions that delimit the authorised technical field
The same organisation may appear under several EU legal acts, but its permission under one act does not migrate into another. An MDR designation does not create an IVDR designation, and a designation under an older directive does not by itself prove designation under the current regulation.
04
The scope page is where the real answer lives #
“This body is MDR designated” is only the opening statement. The manufacturer must still establish that the published scope covers the specific device and the conformity assessment activities required for it.
Commission Implementing Regulation (EU) 2017/2185 creates a multidimensional code system. Codes can reflect design and intended purpose, special device characteristics, technologies and processes. Several codes may therefore describe one product.
Intended purpose · active status · invasiveness · materials · software · sterilisation · technology
Device codes · horizontal codes · conformity activities · published conditions
Class I, IIa, IIb and III describe device risk and drive the conformity route. MDA, MDN, MDS and MDT codes help define notified-body competence and scope. One does not replace the other.
05
The code families describe different dimensions #
The letters are compact, but the logic is not. For MDR devices, the main families divide the question into product type and cross-cutting characteristics.
Device-type codes for active implantable and active non-implantable products
Device-type codes for non-active implants, instruments and other non-active products
Horizontal codes for features such as medicinal substances, tissues, sterilisation or software
Horizontal codes for manufacturing technologies and specialised material processes
MDCG 2019-14 explains that assignment is not always straightforward and the codes can be broad. The notified body verifies the manufacturer’s proposed assignment during application review and makes the final assignment while checking whether suitable resources are available.
06
NANDO confirms permission, not appetite #
A perfect scope match still does not mean the body will accept the application. NANDO is a regulatory register, not a live sales pipeline.
After the legal-scope check, the manufacturer still needs direct confirmation of application acceptance, resources, technical competence, timeline, language and fees.
07
NANDO and EUDAMED answer different questions #
The two systems are connected to the same regulatory ecosystem, but they are not interchangeable. NANDO centres on notification and lawful designation scope. The EUDAMED Notified Bodies and Certificates module centres on conformity assessments and certificate data.
Who is notified under which legislation and for which conformity activities and device types?
Body · number · legislation · scopeWhat conformity assessment and certificate information has been registered in the medical-device database?
Assessment · certificate · status · device linksThe Notified Bodies and Certificates module became mandatory to use on 28 May 2026. NANDO remains the place to verify the body’s published designation and scope.
08
NANDO is useful before, during and after selection #
The database is not only a place to search when a quotation is needed. It is a verification point throughout the relationship with a notified body.
Filter by MDR or IVDR, then inspect scope before spending time on outreach.
Compare the device characteristics and conformity route with the published designation.
Keep the official body number and relevant scope aligned with contracts and certification records.
A new intended purpose, technology, material or manufacturing process can alter the code set.
Confirm that an organisation presented as a notified body is listed for the relevant legislation and work.
09
Most NANDO mistakes begin with a shortcut #
A familiar name can appear under the wrong legislation or through a different legal entity.
The decisive device codes, conformity activities and conditions remain unchecked.
An older MDD or AIMDD notification does not prove current MDR designation.
Special characteristics, software, sterilisation or manufacturing technologies may require additional codes.
Legal authority says nothing about current intake, queue length or commercial interest.
A body’s designation and a specific certificate are different verification questions.
10
Run a six-gate verification before outreach #
A fast check can prevent a slow rejection. Save the result with the shortlist so the decision remains traceable.
Confirm MDR 2017/745 or IVDR 2017/746 rather than a legacy directive.
Match the official name, country, address and four-digit identification number.
Check that the required assessment activities fall within the notification.
Map the relevant device-type and horizontal codes against the published scope.
Read restrictions, conditions and notes rather than relying on a search-result row.
Use the live NANDO entry and retain the date on which the check was performed.
11
After the legal match comes the operational match #
NANDO should narrow the field, not make the final decision. A defensible shortlist combines published scope with evidence that the body can realistically support the product and certification plan.
A short lead time or attractive quotation cannot cure a missing legal scope. Confirm permission first, then compare performance.
12
Keep one durable rule #
NANDO is authoritative for the published notification. It is not authoritative for everything a manufacturer wants to know about a potential certification partner.
First ask whether the body is legally designated for the work. Then ask whether the body is operationally able and willing to do it.
That sequence turns NANDO from a directory into a useful regulatory control.
Official sources
- European Commission NANDO information system
- European Commission overview of notified bodies for medical devices
- Consolidated Regulation EU 2017/745 on medical devices
- Consolidated Regulation EU 2017/746 on in vitro diagnostic medical devices
- Commission Implementing Regulation EU 2017/2185 on designation codes
- MDCG 2019-14 guidance on the use of MDR and IVDR codes
- European Commission EUDAMED Notified Bodies and Certificates module
- European Commission overview of notified bodies and NANDO
The final signal
A four-digit number opens the file. The scope determines whether the file is relevant.
NANDO gives manufacturers a rare thing in regulatory work: a public, official and regularly updated starting point.
Its value depends on reading past the name, past the country and past the number to the legislation, activities, codes and conditions underneath.
NANDO does not select the notified body for you. It prevents you from selecting one that is not authorised for the work.
Notified-body strategy
Need to translate a complex product into the right designation codes and a realistic notified-body shortlist?
Discuss your notified-body route ↗From the knowledge centre
