Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC

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Rincewind

Rincewind

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#2
#2
Thank you Marcelo,
does this mean if the notified body disbands their medical device department as they will not continue to offer services regarding MDD or MDR, that their certificates will be void on 26th may 2020? Even if the date on the certificate states, for example, 2022?

That is how I interpret:
[...]it is required that the notified body that issued the certificate – under a valid designation – continues to be responsible for the appropriate surveillance activities with respect to all of the applicable requirements [...]

Any thoughts on this?
 
M

Marcelo

Inactive Registered Visitor
#3
#3
If a notified body under the MDD disbands , their certificates will be void in 30 days, as required by the MDD. Please note that this has nothing to do with the transition period, these are the rules of the MDD (as they had always been). In the case of the transition, the certificate will still be under MDD rules, and the additional MDR rules (PMS, etc.) do not change this requirement.

The MDR changes the timeframe after the NB disbands to 6 months.
 
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