MDR Classification of Medical devices

MDR ClassFinder finds the risk class of your medical device

The EU Medical Device Regulation (MDR) [1]

Lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the EU.

Applies to clinical investigations concerning such medical devices and accessories conducted in the EU.

Classification of devices

Medical Devices shall be divided into risk classes, taking into account the intended purpose of the devices and their inherent risks. Classification is done in accordance with Annex VIII of the MDR.

[1] Official name: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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