Notified Bodies for Medical Devices
Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities.
A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
- The Directive: MDD 93/42/EEC
- Technical File
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Risks of Non-Compliance
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection needs!Get in touch