Reply to post: Re: Forced to support forever

Do we need Windows patch legislation?

Nattrash

Re: Forced to support forever

@AC

You're right, especially after the regulatory MDD changes in April this year. And with those changes the discussion about who should "service" might also be answered. After all, the MDD obliges the manufacturer to "monitor continuously" the performance of the device in every day use, and this is not necessarily connected to PMS studies (although could be of course, and seen as favourable). And indeed, with these changes there is now a much bigger emphasis on risk management/ avoidance. With that in mind, and the realisation that according to classification, software that drives a device is seen as an active medical device, and falls in the same device class as the device it drives, I see discussions about the "who, how, what, and when" of the obligation to service on the horizon...

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