MEDDEV 2.1/6 2016
By Mitch on Wednesday, 10 August 2016, 10:09 - Regulations - Permalink
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
Useful summary as ever.
Have you seen the updated - and now interactive - MHRA guidance on standalone software and apps?
Thanks
No, thanks for the tip!