Abstract blue background featuring three curved, darker blue stripes arching from the lower right corner toward the upper right, set against a gradient of deep blue tones—symbolizing the structured paths often navigated by notified bodies.

What Are Notified Bodies and What Are Their Responsibilities?

Notified Bodies are independent organisations officially designated by EU member states to carry out specific tasks related to the assessment and certification of products in the EU. For medical devices and in vitro diagnostics (IVDs), they assess whether the requirements of Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) are met – a prerequisite for CE marking and EU market access. Core activities include:

  • Conformity assessment and certification under the MDR/IVDR
  • Review of the technical documentation
  • Auditing of the quality management system
  • Inspections and surveillance, including unannounced audits

Note: Notified Bodies are not regulatory authorities and do not provide technical or regulatory advice.

When Do Medical Devices and IVDs Need a Notified Body?

A Notified Body is required for the following:

  • MDR: all classes except Class I

  • IVDR: all classes except Class A non-sterile IVDs. Class A sterile and Class B, C, and D devices require a Notified Body. Without a successful conformity assessment procedure, neither CE marking nor market access can be obtained (for non-sterile Class A devices, the IVDR permits a manufacturer’s declaration of conformity; see IVDR Article 48(10)).

Notified Bodies are therefore the key institutions for obtaining EU market access for a medical device or IVD.

We are happy to support you in your interactions with Notified Bodies. Contact us!

Get in touch

Dr. Stefanie Gaupp, Team Lead Study Management

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CE: European Conformity

EU: European Union

IVDs: In vitro diagnostics

IVDR: In Vitro Diagnostic Regulation

MDR: Medical Device Regulation

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