Hi all !
First post on this forum! This is also my first job in a regulatory position and I could really do with some pointers
My question is related to the labelling requirements for registration / notification of medical devices in Europe.
For context, my company is manufacturing class IIa - IIb devices with several variants, with a different product code for each variant (e.g. masks with several sizes) - these different product codes appear on the labelling of the devices. Since we register all or most of our products' variants in Europe, this means there are several hundred product codes registered by countries (and some codes are region-specific so you can have a code for product A variant A region 1 and a different code for Product A variant A region 2, so that's even more codes globally).
With MDR coming we will have to update the registration of all our products with labeling aligned with MDR, which is a pain since we have to ask someone to generate the label for each code we need to submit, a process taking up to half an hour per code.
Thus my question is: in which EU countries would it be acceptable to send a "sample" label and indicate in a table the data subject to change (i.e. name and product code)? Our labels are built on a template so all that is changing is the name and product code.
It is my understanding that every country requiring the labels as part of the registration / notification process is asking for the actual labels of the products being registered, but do you have experience suggesting otherwise or actual texts of law indicating this can be done?
Thank you in advance for your advice!
First post on this forum! This is also my first job in a regulatory position and I could really do with some pointers
My question is related to the labelling requirements for registration / notification of medical devices in Europe.
For context, my company is manufacturing class IIa - IIb devices with several variants, with a different product code for each variant (e.g. masks with several sizes) - these different product codes appear on the labelling of the devices. Since we register all or most of our products' variants in Europe, this means there are several hundred product codes registered by countries (and some codes are region-specific so you can have a code for product A variant A region 1 and a different code for Product A variant A region 2, so that's even more codes globally).
With MDR coming we will have to update the registration of all our products with labeling aligned with MDR, which is a pain since we have to ask someone to generate the label for each code we need to submit, a process taking up to half an hour per code.
Thus my question is: in which EU countries would it be acceptable to send a "sample" label and indicate in a table the data subject to change (i.e. name and product code)? Our labels are built on a template so all that is changing is the name and product code.
It is my understanding that every country requiring the labels as part of the registration / notification process is asking for the actual labels of the products being registered, but do you have experience suggesting otherwise or actual texts of law indicating this can be done?
Thank you in advance for your advice!