Notified Bodies for In-Vitro Diagnostic Medical Devices under IVDR

Notified Bodies for In-Vitro Diagnostic Medical Devices under IVDR

Notified Bodies play a key role in supporting manufacturers to place  only safe and compliant in-vitro diagnostic medical devices on the EU Market.  They are controlling the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic 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 audit the quality management system of  the manufacturer and review the technical documentation of IVD As, B, C,  D. Notified bodies will issue EU Technical Documentation Assessment Certificates, EU Quality Management System Certificate, EU Production  Quality Assurance Certificate and EU Type Examination Certificates  depending on the conformity assessment procedure selected.

All  notified bodies which have been designated under Directive 98/79/EC need  to be re-designated under the IVDR.  Under the IVDR, the requirements  that notified bodies must meet have increased drastically. Those  notified bodies are also subject to a peer review every 3 years. As a  result of this process, we expect that the number of notified bodies designated under IVDR will be very limited. Notified bodies which have  been designated under the IVD can issue the IVDR conformity assessment  certificates. Manufacturer  can consult the list of designated notified  bodies under IVDR in the European Commission´s directory of Notified  Bodies (NANDO website).

Notified  bodies shall conduct surveillance audit on at least an annual basis as  well as unannounced audit of manufacturer and where applicable  subcontractors and suppliers.

For class B and class C devices,  notified shall draw up and keep up to date,  a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer’s  application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate.

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