Notified Bodies for In-Vitro Diagnostic Medical Devices

Notified Bodies for In-Vitro Diagnostic Medical Devices

Notified Bodies are tasked with ensuring that certain classes of  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 give them the  official accreditation. Their role mainly consists of inspecting the  technical documentation 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).


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Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection and Negotiation needs!

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