Technical File Submission? - Medical Devices no longer made

Peter Selvey

Staff member
Super Moderator
#11
Well, this is just my take, may not be correct:

You need to keep the documentation avaliable, but not up to date.

The CE marking directives really provide a "clearance for sale" function. Thus most of the provisions are applicable only at the time of sale. Stop selling and those provisions stop being applicable.

Of course, nothing here absolves you of any responsibility for product in the market. Here, the EU product liability directive (85/374/EEC) takes over, which by the way has a time limit of 10 years from the time of sale, well beyond the MDD's minimum 5 year retention period.

And of course there are some special cases (e.g. implantables, recalls) where some greater post market activity is expected. But in general the provisions of the directive are pre-sale related (which may include, feedback from the market).
 
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