Notified Body
Notified Bodies are independent conformity assessment organisations officially designated by national authorities of EU Member States in accordance with the relevant EU regulations. Their competences and scopes are published in the European Commission's NANDO database.
For medical devices under MDR (EU) 2017/745, Notified Body involvement is mandatory from Class IIa upwards. For PPE under Regulation (EU) 2016/425, from Category II upwards. Their tasks include:
- EU type-examination
- Surveillance of manufacturers' quality management systems
- Review of technical documentation
- Issue of certificates
Each Notified Body receives a unique identification number (e.g. 0123) that must appear on the product and in the EU Declaration of Conformity.
Notified Bodies are not public authorities – they operate under private law but are subject to state supervision and must meet the requirements of the applicable EU regulation. Under MDR, the requirements for Notified Bodies were significantly strengthened compared to the former MDD.
Frequently asked questions
When must a Notified Body be involved?
For medical devices from Class IIa (MDR) and for PPE from Category II (PPE Regulation). Class I medical devices and Category I PPE do not require a Notified Body – except for Class Is, Im, or Ir.
Are Notified Bodies government authorities?
No. Notified Bodies are private-law organisations designated and supervised by national authorities (e.g. ZLG in Germany) under strict criteria. They act in support of regulation but not as sovereign authorities.