Notified bodies · MDR · IVDR
How to use NANDO to find a notified body for medical devices
NANDO is the European Commission’s official directory of designated notified bodies. This guide shows how to search it, read a designation scope and build a useful shortlist for an MDR or IVDR conformity assessment.
Verify scope before contacting a notified body
What NANDO tells you
Use it to verify designation, not availability
Official scope
NANDO shows whether a body is designated under MDR or IVDR and the scope covered by that designation.
Not a capacity check
A listing does not show current lead time, commercial availability or willingness to accept your application.
Before searching
Know what you need the body to assess
Have a concise device profile ready, including the intended purpose, risk class, applicable regulation, proposed conformity assessment route and the relevant designation codes. NANDO can then be used to test whether a notified body’s legal scope covers your case.
Access the NANDO database #
Open the European Commission’s notified-body directory. NANDO now sits within the Commission’s Single Market Compliance Space, so the surrounding interface may look different from older screenshots or guides.
European Commission notified-body directory↗Locate the search options #
The directory provides several ways to narrow the list. Labels and positions may change slightly when the Commission updates the interface.
- Search by country useful when location, language or local access matters
- Search by legislation the most reliable starting point for an MDR or IVDR search
- Free search useful when you already know a body’s name or four-digit identification number
Select search by legislation #
If you do not already have a candidate body, begin with legislation. Select Regulation (EU) 2017/745 for medical devices or Regulation (EU) 2017/746 for in vitro diagnostic medical devices.
Browse the list of notified bodies #
The results show bodies designated under the selected regulation. Browse the list or use the available filters. A country filter can make the list easier to manage, but country alone does not establish technical suitability.
Select a notified body #
Open the record for a body that may match your needs. Do not stop at the name or country. The detailed designation record is where you verify what the body is legally permitted to assess.
Review notified-body information #
- Identification number the four-digit number associated with the notified body
- Address and contact information the official details recorded in NANDO
- Legislation and notification scope the regulation, procedures, product codes and any limitations covered by the designation
Examine the notification details #
Confirm that the designation covers the conformity assessment procedure relevant to your device and read the code descriptions, including any conditions or limitations.
Clarification These designation codes help define a notified body’s scope and competence. They are not the MDR or IVDR risk class of the device.
Evaluate the scope of notification #
Compare your device profile and proposed code set with the published scope. A match means the body may be eligible to assess that type of device. It does not yet confirm acceptance, capacity, timetable or commercial terms.
If the fit is uncertain, ask the body to confirm it in writing rather than relying on a broad or approximate match.
Contact the notified body #
Use the official contact details or the application route on the body’s own website. Make the first enquiry specific enough for an informed response.
Include in the enquiry
- device and intended purpose
- risk class and rationale
- MDR or IVDR route
- proposed designation codes
- QMS and documentation status
- target certification timeline
Important notes
What the shortlist still cannot tell you
- A notified body may decline an application because of scope, capacity, commercial policy, project readiness or other legitimate considerations.
- Designation under the right regulation is necessary, but the exact scope and any limitations must also cover the device and the chosen procedure.
- Location can matter, but relevant expertise, working language, capacity, timetable and communication are often more important.
- Prepare a coherent device summary and evidence of regulatory readiness before approaching candidates. This makes scope screening faster and more useful.
Conclusion
Use NANDO to establish eligibility, then verify practical fit
NANDO is the authoritative starting point for finding notified bodies designated under MDR and IVDR. A sound selection process moves from legislation to designation scope, then from scope to direct confirmation of expertise, capacity and project fit.
European Commission overview of notified bodies ↗Notified-body preparation
Need help defining the right scope before you approach a notified body?
Discuss your regulatory pathway ↗From the knowledge centre
