What notified bodies do
Notified body obligations are set out in MDR Art. 36–50 and Annex VII / IVDR Art. 33–47 and Annex VII. Notified bodies are designated by national competent authorities and supervised by the MDCG.
This site provides general information only and does not constitute legal or regulatory advice.
Role of notified bodies in the EU system
A notified body (NB) is a private, independent, third-party organisation that has been assessed and officially designated by a national competent authority to carry out conformity assessment tasks under MDR and/or IVDR. They are the mechanism by which higher-risk devices receive independent technical scrutiny before CE marking.
Notified bodies are not regulators — they do not approve or refuse to approve devices in the same way a regulatory agency does. Instead, they assess whether a manufacturer has demonstrated compliance with MDR/IVDR requirements, and issue certificates accordingly.
Core functions of a notified body
1. QMS assessment and certification
Under Annex IX, the NB assesses the manufacturer's quality management system — verifying it meets EN ISO 13485 and all MDR/IVDR-specific requirements. This involves initial documentary review and on-site audits.
2. Technical documentation review
The NB reviews technical documentation (Annex II) for representative devices — assessing the GSPR cross-reference, risk management file, design and manufacturing information, and critically the clinical evaluation or performance evaluation report.
3. Type examination (Annex X)
Where Annex X is used, the NB examines and tests a representative specimen of the device against the technical documentation and applicable standards.
4. Surveillance audits
After certification, the NB conducts ongoing surveillance:
- Announced periodic audits: typically annually
- Unannounced audits: mandatory for Class III (MDR Art. 93) and Class D (IVDR)
5. Certificate issuance, renewal, and suspension
NBs issue EU certificates, renew them at expiry, suspend them where concerns arise, and withdraw them where non-conformities are not resolved.
6. SSCP validation
For Class III devices and implantables (MDR) and Class D/C IVDs (IVDR), the NB validates the Summary of Safety and Clinical Performance before it is published on EUDAMED.
7. Clinical evaluation consultation (Art. 54 MDR)
For certain Class III devices, the NB must submit the clinical evaluation to an expert panel for scientific opinion before issuing a certificate.
8. Companion diagnostic consultation (IVDR Art. 48(3))
Before issuing a certificate for a companion diagnostic, the NB must seek an opinion from EMA or a national medicines authority.
What notified bodies do NOT do
- They do not approve or reject devices on safety grounds independently of the manufacturer — their role is to assess whether the manufacturer has demonstrated compliance
- They do not replace the manufacturer's own technical and clinical assessment — they review it
- They are not responsible for the safety of devices they certify — that responsibility remains with the manufacturer
- They do not conduct post-market surveillance of devices — that is the manufacturer's obligation
The NANDO database
The NANDO database (New Approach Notified and Designated Organisations) is the official EU register of all designated notified bodies. It lists:
- Each NB's name, country, and identification number
- The regulations and annexes under which each NB is designated
- The scope of designation — device types and categories each NB is authorised to assess
All EU notified bodies must be in NANDO to be legally authorised to issue MDR/IVDR certificates. A certificate from a body not listed in NANDO is not valid.
URL: ec.europa.eu/growth/tools-databases/nando
Related pages
- How to choose a notified body
- NANDO database
- Audit process & timelines
- Unannounced audits
- Scrutiny procedure (Art. 54)
- Conformity assessment overview
Official references
| Reference | Description |
|---|---|
| MDR Art. 36–50 | Notified body framework |
| MDR Annex VII | NB designation requirements |
| MDR Art. 93 | Unannounced audits |
| MDR Art. 54 | Expert panel consultation |
| IVDR Art. 33–47 | IVDR NB framework |
| NANDO database | ec.europa.eu/growth/tools-databases/nando |