What is a Notified Body and when do I need one under EU MDR?
MDR Article 36–50 · Annex IX, X, XI · NANDO database
The short answer
A Notified Body (NB) is an independent third-party organisation designated by an EU member state to conduct conformity assessments under MDR. NBs are mandatory for Class IIa, IIb, and III devices. Standard Class I devices do not require a NB — but Class I sterile, measuring, and reusable surgical instruments need NB involvement for specific aspects.
What a Notified Body does
- Audits the manufacturer's Quality Management System (QMS) against Annex IX Chapter I
- Reviews technical documentation including clinical evaluation and GSPR checklist
- Issues EU certificates of conformity (CE certificates)
- Conducts unannounced audits as part of ongoing surveillance
- Monitors post-market changes that may affect certification
- For Class III and implantable Class IIb: triggers the clinical evaluation consultation procedure (CECP) — assessment submitted to an EU expert panel (Art. 54 + Annex IX Section 5.1)
Conformity assessment routes by device class
| Class | Conformity route | NB involvement |
|---|---|---|
| Class I (standard) | Self-certification — Annex IV Declaration of Conformity | None |
| Class I sterile / measuring / reusable (Is/Im/Ir) | Annex IV + Annex IX or XI for specific aspects | NB audits QMS or tech docs for sterility, measuring, or reuse aspects |
| Class IIa | Annex IX (QMS + tech doc review) or Annex XI (product verification) | Mandatory |
| Class IIb | Annex IX (QMS + tech doc review) or Annex IX + X (type examination) | Mandatory |
| Class III | Annex IX + clinical evaluation consultation (CECP, Art. 54), or Annex X (type examination) | Mandatory + scrutiny procedure |
How to choose a Notified Body
All EU-designated NBs are listed in the NANDO (New Approach Notified and Designated Organisations) database at ec.europa.eu. When selecting a NB, consider:
- Scope: The NB must be designated for the specific device type and MDR code applicable to your device
- Capacity: Many NBs have long waiting lists — begin engagement 12–24 months before your target CE date
- Fees: Typically range from €20,000 for simple IIa devices to €100,000+ for Class III / complex IIb
- Location and language: Can affect practical communication; does not affect legal standing within the EU
- Experience in your product area: A NB with deep software expertise matters for SaMD manufacturers
EUDAMED and NB certificates
NB certificates will be publicly accessible in the EUDAMED database from May 2026 when the Certificates and Notified Bodies module becomes mandatory. Manufacturers and third parties (including NCAs) will be able to verify certificate status in real time.
Frequently asked questions
Can the same NB certify for both MDR and IVDR?
A NB must be separately designated for MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). Many NBs hold both designations, but you must verify scope for your specific device type.
What happens if my NB loses its designation?
If a NB is de-designated or its designation lapses, certificates it issued remain valid for a limited transition period. Manufacturers must transfer to a new NB. EUDAMED tracks designation status and competent authorities manage the transition process.
I sell only in one EU country — do I still need a NB?
Yes. EU MDR applies across all 27 member states. Even if you only sell in Germany or France, the CE marking requirements — including NB involvement for Class IIa/IIb/III — apply. There is no single-country exemption.
How long does NB certification take?
Typically 12–24 months from first engagement to certificate issuance, depending on NB capacity, device complexity, and the completeness of your technical documentation when submitted.