Medical Device Regulations

Learn more about how to align with the new requirements of the EU-MDR (2017/745)


European Medical Device Regulation (EU-MDR 2017/745)

The Medical Device Regulation was officially published on May 5, 2017, and came into force on May 25, 2017. Currently approved medical device manufacturers had an initial three-year transition time to May 26, 2020, which was changed to May 26, 2021, to meet regulatory requirements. Click here to access the MDR on the Official Journal of the European Union.

The new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies who must involve in the approval process of medical devices other than self-declaration class I devices. All manufacturers of Class I to III medical devices must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products

The EU-MDR brings many changes to the EU Medical Device Directives, including many definitions, reclassifications, new conformity assessment routes, new Notified Body designations, and more. Stricter requirements on the safety of ingredients, on clinical evidence, and on consistency in regulatory compliance. Much more detailed in the essential principles, and above all: no grandfathering!

Get Trained on the Medical Device Regulations Today

Since a large number of medical devices will now require a Conformity Assessment Procedure based on the MDR requirements in order to be placed on the European market, it is important to start in time with the transition to the new requirements. You will need advanced preparation, Qserve could train you on all steps of the implementation of the MDR. 

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