Notified Body

A Notified Body is an organization designated by an EU Member State to assess whether manufacturers and their medical devices meet the requirements set out in the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Role of Notified Bodies:
- Assess device conformity to EU MDR/IVDR
- Review technical documentation
- Conduct quality management system audits
- Issue CE certificates
- Perform unannounced audits
- Monitor post-market compliance

When you need a Notified Body:
- Class IIa, IIb, III devices - Always required
- Class I sterile - Required for sterile aspects
- Class I with measuring function - Required for measuring aspects
- Class I reusable surgical - Required
- All IVDs except Class A - Required

Conformity assessment procedures:
- Annex IX - Quality management system assessment
- Annex X - Type examination
- Annex XI - Production quality assurance

Choosing a Notified Body:
1. Check designation scope covers your device type
2. Verify experience with similar devices
3. Assess capacity and timeline
4. Review audit frequency and approach
5. Consider geographic coverage

Current challenges:
- Limited Notified Body capacity under EU MDR
- Longer wait times for certification
- Stricter requirements than under MDD
- Some NBs withdrew from medical device sector

Major Notified Bodies:
- BSI (UK - pre-Brexit)
- TÜV SÜD (Germany)
- TÜV Rheinland (Germany)
- SGS (Belgium)
- DEKRA (Netherlands)

The number of designated Notified Bodies decreased significantly with EU MDR implementation.