Bite-sized Knowledge: Medical Device Regulation

March 6, 2020

A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective provided by the European Union, each country is free to develop its own measures to achieve this objective.  

Figure 1: Overview of the difference between Direction and Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group.

Citizens and Companies implement their policy (act) according to their National law which is an interpretation of the European law.

Citizens and companies implement their policy (act) according to European law.

What are the changes in Medical Devices regulation?

The European Parliament has replaced Medical Devices Directives (MDD, AIMD, IVDD) by Regulations (MDR and IVDR).

Figure 2: The changes in Medical Devices Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group

Medical Device Directive and Active Implantable Medical Device Directive have been fused into the Medical Device Regulation. In-vitro Diagnostic Device Directive has become In-vitro Diagnostic Device Regulation.

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Author: Alix Auter, Life Science Consultant KVALITO

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