Notified body selection

Notified Bodies for Medical Devices and In Vitro Diagnostics under the EU MDR and EU IVDR

NOTIFIED BODY

Why need a Notified Body?

Notified Bodies play a key role in supporting manufacturers to place compliant medical devices on the European market. Notified Bodies are responsible for validation and (re-) certifying Medical Devices and In Vitro Diagnostics, allowing products market access in Europe. Both new regulations (MDR2017/747 and IVDR 2017/748) introduce new obligations for Notified bodies

Need support selecting a Notified Body?

The process of selecting a notified body is an important undertaking. In the current regulatory environment, this process is even more critical. The experts of Qserve can support you with this important task.

What are the tasks of Notified Bodies?

In the case of medium and high-risk medical devices, a notified body will examine whether they observe all relevant legislation to be allowed on to the European market. This means the following medical devices:

  • class I devices with a measurement function or sterility, class IIa, class IIb and class III (refer to Annex IX of the Medical Devices Directive 93/42/EEC);
  • active implantable medical devices (Active Implantable Medical Devices Directive 90/385/EEC); 
  • in vitro diagnostic medical devices, Annex 2, List A and List B, and self-tests (IVD Directive 98/79/EC);

Please check the overview for all MDR designated Notified bodies and for the IVDR notified bodies click here.

Interested in our EU MDR services?

We would like to tell you more about the possibilities that Qserve offers as a Regulatory Consultant.

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