Software in Medical Devices, by MD101 Consulting

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Tuesday, 14 June 2022

MDCG 2022-11 - Monty Python and the Holy Grail

Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?

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Friday, 13 May 2022

Software as a Medical Device Post-Market Surveillance

Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.

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Thursday, 31 October 2019

Is my software in class IIa, IIb, or III, Dark Fate

Here we are! White smoke over the European Parliament! The MDCG 2019-11 guidance on qualification and classification of medical device software (MDSW) was published the 11th of October 2019.

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Sunday, 26 May 2019

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

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

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