A Notified Body is an independent certification organization that is “notified” by a European Member State’s Competent Authority to determine if a product or system meets applicable requirements for CE marking.
The European new approach directives require the involvement of third parties in the conformity assessment of certain products.
|The Competent Authorities, for medical devices, are usually the individual Member States’ Ministry of Health, or an agency within the Ministry of Health. The European Commission is the executive branch of the EU, and is responsible for the Directive’s proper execution. Each country (Member State) has its own Competent Authority in charge of market surveillance and designating and monitoring the independent Conformity Assessment Bodies.|
The European Commission lists these designated Conformity Assessment Bodies. The procedure to designate and list the Conformity Assessment Bodies is called “notification,” hence the name “Notified Body.” Competent Authorities continually assess Notified Bodies to ensure that they maintain their competence and expertise to a directive.
Notified Bodies in the EEA Member States
The Enterprise and Industry Directorate-General at the European Commission provides lists of the Notified Bodies in the NANDO (New Approach Notified and Designated Organizations) information system:
- NANDO Homepage
- Notified Bodies for active implantable medical devices
- Notified Bodies for medical devices
- Notified Bodies for in vitro diagnostic medical devices
For medical devices of Class I Sterile, Class I Measuring,
Class IIa, Class IIb, Class III –
Notified Body involvement is mandatory!