Website of TEAM-NB (Article in Scrip Regulatory Affair by Vibha Sharma) shows MEDDEV 2.7/1 is going to be revised in May.
This revision seems to be very serious from the description.
If this revision suddenly apply all medical devices, no medical devices can be placed on EU market for some time.
So, I think transition period must be given.
However, there is no description related to transition period.
Does anyone give us information about transition period?
Thank you.
This revision seems to be very serious from the description.
If this revision suddenly apply all medical devices, no medical devices can be placed on EU market for some time.
So, I think transition period must be given.
However, there is no description related to transition period.
Does anyone give us information about transition period?
Thank you.