What is the latest update in MDR (Medical Device Regulation) ?

Update on MDR (Medical Device Regulation)

This update is with regard to the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 for 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. The requirements of the new regulation are more complex than the previous one and are different by product type. The updated MDR will come into effect from May 25, 2021. With the entry into force of the MDR, the European Union demands the observance of new, significantly stricter regulations for medical devices.

Base on the MDR, medical based power supply is not classified as a medical device. Therefore, by itself, a power supply unit cannot be classified as an accessory for a medical device. Consequently, MDR cannot be applied to an independently standard power supply unit.

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