Find a Notified Body for MDR Certification
Medical devices above Class I (non-sterile, non-measuring) need conformity assessment from a Notified Body designated under MDR 2017/745. Filter this directory by MDR designation and country, or describe your device and reach several matching bodies at once.
Which device classes need a Notified Body under MDR?
| Device class | NB involvement |
|---|---|
| Class I (non-sterile, non-measuring) | Not required — self-declaration |
| Class I, sterile or with a measuring function | Required for that aspect only (Annex XI) |
| Class IIa | Required — technical documentation assessment |
| Class IIb | Required — type examination or QMS audit |
| Class III | Required — design dossier examination + full QMS audit |
| Annex XVI aesthetic devices | Required regardless of class |
Why manufacturers struggle to find one
Designation scope is coded in EUDAMED by MDD codes and device categories, not a simple "does MDR" flag — two NBs can both be MDR-designated and cover completely different device types. Combined with waitlists at several major bodies, matching a specific device to a body with both the right scope and open capacity takes real research.
Frequently asked questions
- Do all medical devices need an MDR Notified Body?
- No. Class I devices that are non-sterile and have no measuring function can self-declare. Class I sterile or measuring devices need NB involvement for that aspect only. Class IIa, IIb, III, and all Annex XVI aesthetic devices need full NB conformity assessment.
- Why is NB capacity such a problem under MDR?
- Notified Body capacity has been constrained since MDR 2017/745 took effect — many NBs run waitlists or have stopped accepting certain device categories. Designation scope is coded by MDD codes in EUDAMED, so a body’s general MDR designation doesn’t guarantee it covers your specific device.
- What do I need before contacting a Notified Body?
- Device classification, applicable GMDN/MDD codes, target markets, and the current state of your technical documentation. The more precise this is, the faster a Notified Body can confirm whether your device is within their designated scope.
- How does this directory help?
- Filter Notified Bodies by MDR designation and country directly — every listing shows real contact details, no account required. Describe your device once and reach several matching bodies instead of searching EUDAMED and cold-emailing each one.