Notified Bodies for In-Vitro Diagnostic Medical Devices

Notified Bodies are tasked with ensuring that all the in-vitro diagnostic medical devices placed on the EU Market are safe and compliant. They assist the manufacturers to carry out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices. There are certain criteria that a Notified Body must meet before the EU Authorities can designate them. Their role mainly consists of inspecting the technical documentations of Self-Testing IVD medical devices and IVDs listed on the Directive’s Annex II (list A and list B). Selecting a Notified Body for an in-vitro diagnostic medical device is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website). However, as 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 in-vitro diagnostic medical devices, please see our Notified Body Selection page.

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in In-Vitro Diagnostic Medical Device Directive