Approval process for modifications to a medical device with a CE Mark

P

porscheuberalles

#1
I haven't been able to find what I'm looking for in the MDD so I was hoping someone could point me in the right direction. What is the approval process for modifications to a device with a CE mark? Are there criteria for changes that require a new approval vs changes that don't require new approval?
Also, I was wondering if anyone has a recommendation for a Notified Body; preferably one with sensible feedback times.
 
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M

MIREGMGR

#2
Re: modifications to a device with the CE mark

What class is the subject device?

There is no supervision of changes to a Class I device, unless you are located outside EU and for some circumstantial reason your EU Rep becomes involved in the process. Class I-s devices are supervised only in regard to sterilization and sterile barrier packaging.

Class IIa, IIb and III devices of course have increasing amounts of NB interaction and pre-approval.
 
P

porscheuberalles

#3
Re: modifications to a device with the CE mark

Thanks for the reply. It's a class IIa device. Do all changes require all documentation being sent to the NB? Is it the same process as the initial approval or is there another process for modifications to an existing device?
 
#5
The decision to report design changes and changes to the quality system relies upon the determination of whether the change was a "significant change" or not. Health Canada has a document "Guidance for Interpretation of Significant Change of a Medical Device" with decision-making flowcharts that can assist in this decision. The document is located at:

hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/signchng_modimportante-eng.php
 
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