Software in Medical Devices, a blog by MD101 Consulting

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MEDDEV 2.1/6 2016

A new version of the MEDDEV 2.1/6 was published in July 2016.

The first version of 2012 was a major breakthrough. The new version won't change you life. Almost nothing new, excepted a few definitions on software, input data, output data, a remarkable reference to IMDRF definitions, and a non-significant update of the first decision tree.

Add to that a few typos, and you have the new version of the MEDDEV:

  • "lossless compression" disappeared from the decision tree (was it intentional?) but is still present in the explanations of decision step 3,
  • Decision step 7 doesn't have any explanation.


MEDDEV for nothing ♫ and tips for free ♬.



Comments

1. On Friday 23 September 2016, 09:36 by Ben

Useful summary as ever.

Have you seen the updated - and now interactive - MHRA guidance on standalone software and apps?

Thanks

2. On Friday 23 September 2016, 22:52 by Mitch

No, thanks for the tip!

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