Notified Bodies for Medical Devices under MDR
Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They are controlling 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 officially accredited by the EU Commission. A key aspect of their role is to audit the quality management system of the manufacturer and review the technical documentation of devices in class Is/Im/Ir, IIa, IIb and III. Notified bodies will issue before issuing CE Certificates and/or Technical Documentation Assessment or Type Examination Certificates depending on the class of the device. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
Scrutiny by Competent Authorities over Notified Bodies has been reinforced with the MDR, the number of existing Notified Bodies have dramatically decreased throughout the years, therefore selecting a Notified Body device can be a complex process, it is also advised that an external expert supports this critical decision. For more information about Notified Body for medical devices, please see our Notified Body Selection page.
Notified bodies shall conduct surveillance on site audit at least on an annual basis as well as unannounced audit of manufacturer and where applicable subcontractors and suppliers.
- The Regulation: MDR 2017/745
- Technical File
- Authorized Representatives
- Custom Made Devices
- Clinical Evaluation & Clinical Investigation
- Systems & Procedure Packs
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