The MDR aims to:

Ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.

Set high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.

Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. 

Text of the MDR

Official Journal of the European Union

About the MDR

Regulation (EU) 2017/745

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