Find a Notified Body for MDR Certification

When do you need an MDR Notified Body?

Under MDR 2017/745, most medical devices require third-party conformity assessment by a Notified Body (NB). Self-declaration without NB involvement is only permitted for Class I non-sterile, non-measuring devices. All higher-risk devices require a designated NB.

Notified Bodies under MDR are officially designated by EU Member States and listed in EUDAMED. Each NB has a specific designation scope — not every NB covers every device type, class or MDD code. Finding one with both current capacity and the right designation scope is the main challenge manufacturers face.

Which device classes require an MDR Notified Body?

Device Class	NB Involvement Required
Class I (non-sterile, non-measuring)	No NB — self-declaration only
Class I sterile or measuring function	NB for the sterility / measuring aspects only
Class IIa	Yes — technical documentation assessment (Annex IX/XI)
Class IIb	Yes — type examination or QMS audit
Class III	Yes — design dossier examination + QMS audit
Annex XVI (aesthetic) devices	Yes — NB required regardless of class

Why finding an MDR Notified Body is difficult

MDR Notified Body capacity has been severely constrained since 2021. Many NBs have waitlists, restricted scopes, or are not accepting new clients for certain device categories. Searching EUDAMED manually and contacting NBs one by one is time-consuming and often results in rejections or no response.

Designation scope in EUDAMED is coded by MDD codes and device categories — matching your specific device to an NB with the right scope requires detailed knowledge of the designation system.

How ECP matching works

Describe your device type, classification, applicable GMDN or MDD codes, target markets and current documentation status. ECP routes your request to Notified Bodies that have indicated availability and whose designation scope matches your product.

You receive NB responses directly with scope confirmation, estimated timelines and next steps — without cold outreach or manual EUDAMED searches.