Software in Medical Devices, by MD101 Consulting

Software in Medical Devices, by MD101 Consulting

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Tag - MDR

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Sunday 26 May 2019

MDR: one year left and too late for class I software

By Mitch on Sunday 26 May 2019, 14:00

Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Why?
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).

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Saturday 6 May 2017

MDR and IVDR published

By Mitch on Saturday 6 May 2017, 10:59 - Regulations

Hello, The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.

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