Approval Process for Medical Devices

The approval process for medical devices follows a certain pattern: Authorities select legally and technically independent, competent bodies called Notified Bodies to independently check that manufacturers are conforming to the Directives and Regulations requirements.

Not all Notified Bodies can check all technologies and not all member states have Notified Bodies

It is important to note here that not all Notified Bodies can check all technologies and not all member states have Notified Bodies. Notified Bodies must be able to demonstrate that they have the clinical, scientific and technical competence to check the technologies for which they are designated.

A small Range of Exceptions

NOTE: There is a small range of medical devices (low risk – class I) and the major part of in vitro diagnostic (IVD) medical devices (low risk – other IVD) that do not need this up front certification! Please note that under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), 80-90% of IVD medical devices will require a Notified Body under the new classification system. 

A list of Notified Bodies is available on the website of the EU Commission. You find a collection of useful links at the end of this article.

As an additional control entity, competent authorities monitor the work of the Notified Bodies. They are also free to check and verify a manufacturers’ compliance with the EU legislation at any time as part of their market surveillance.

The European Commission is not your enemy

Finally, to improve cooperation, the European Commission helps to organize the exchange of experiences between the authorities responsible for market surveillance in order to coordinate uniform implementation. This creates a continuous loop of authority oversight of medical devices and IVD medical devices.

The Medical Devices Regulation (EU) 2017/745 (MDR) and IVDR move this principle one big step forward: The Regulations are directly implemented into national law. On top of that, the new version of the EUDAMED database will enhance supervision mechanisms and collaboration among stakeholders.

List of useful links connected to the Approval Process

Read our article “Notified Body Selection and Change”.
Visit the European Commission website on EUDAMED under the MDR and IVDR.
Find a list of Notified Bodies under the MDR (IVDR will follow soon) on the European Commission website.
Or get in touch with our team if you require further assistance.