Software in Medical Devices, by MD101 Consulting

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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?

They say:
Therefore and in order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalise transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.

Either the MDCG is completely off the ground and should be renamed the MPHG, Monty Python and the Holy Grail, or this is a disguised message to the European Commission.

I keep faith in mankind and lean towards the second solution.

monthy horse.jpeg, Jun 2022

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