Approval Process for Medical Devices

Authorities select legally and technically independent, competent bodies, called Notified Bodies to independently check that manufacturers are conforming to the Directives requirements. It’s important to note here that not all 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.

NOTE: There is a small range of products (low risk – Class I) that do not need this up front certification!

A list of Notified Bodies is available on the website of the EU Commission.

Authorities also double check on what’s going on. They monitor the body in its work, checking and monitoring the details of the files they have approved, typically once a year. They are also free to check and monitor manufacturers’ compliance with the EU legislation as part of their market surveillance.

Finally, to improve cooperation, the Commission helps organise 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.

This belt and braces approach has allowed Europe to efficiently and effectively ensure safety of citizens while guaranteeing the fastest access to life saving innovation to patients and doctors. Europe is able to provide technology to patients 2-3 years ahead of the USA and 5 years ahead of Japan.

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