Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products

Kuldeep Singh

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#1
Hi Everyone

I want to know about Post Market clinical Follow up and CE Marking for our Class IIb medical X-Ray products.

As per our understanding PMCF (Post Market Clinical Follow Up) study is required for devices based on Novel Technology & it is also needed for the Class III, Implantable devices, high risk and long term invasive devices. For PMCF study we have to take the feedback from the user/ patient in respect of device performance & clinical safety. In our case, s patient can’t give the appropriate information/ feedback as good as device user can provide (as user cant judge the X-Ray image). We take the Information from device user (Doctor/ Technician) through PMS.

Most of our CE certified products are being developing, manufacturing, supplying and servicing since 1987 and the medium/long term safety and clinical performance of products are already known and data collected from Post market surveillance activities is sufficient to address the risks. In other hand we have no any Class III, Implantable or user carry devices.
So please guide us, this will be applicable for us as a New MDR requirement or not, if yes then which type of data we have to collect.

CE Marking
# If we place our CE certified Models in countries other than Europe without pasting a CE logo/ Mark on Device Label (Sl. No. Sticker) then these models will be under influence of Notify body/NCA/EAR or not & that device will be considered as a CE mark or not. Please guide…
 
Elsmar Forum Sponsor

FoGia

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#2
Could you reformlulate your question. Provided that you have enough data no you don't need to perform PCMF studies, however the rationale as to why no PCMF studies are needed needs to be stated.
 
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