I am struggling with the IFU and how to handle this in a practical way.. Currently we have devices containing a IFU / Operation Manual which is 30-40 pages per language.
In order to market the device in all EU Member Status this would end up in a book of 700 pages if we combine it.
Since a device can only be market according the national language determined by member state we have a challenge to include the correct language for the specific country.
our idea is now to import all devices to 1 member state including IFU / Operation Manual for that member state. Importer can verify and device is conform.
For each of the National languages manufacturer will translate the IFU / OM and make this available on website, including article number (UDI with DI and PI for version)
Importer will print a bunch of IFU's - depending on needs and keep them on stock (until he is made aware of change by manufacturer conform contractual agreement).
Whenever importer receives order where he needs to include translated IFU he will do so.
The questions;
1) importer is not translating IFU, does article 16.2 A applies?
1.1) if yes, how do I need to read 16.4 " Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3."
does this means that importer needs to have a QMS certified by Notified Body?
2) can IFU be provided separately from medical device or does it needs to be included?
Many thanks for your help on this! Any other ideas are welcome (e-IFU is not possible..)
In order to market the device in all EU Member Status this would end up in a book of 700 pages if we combine it.
Since a device can only be market according the national language determined by member state we have a challenge to include the correct language for the specific country.
our idea is now to import all devices to 1 member state including IFU / Operation Manual for that member state. Importer can verify and device is conform.
For each of the National languages manufacturer will translate the IFU / OM and make this available on website, including article number (UDI with DI and PI for version)
Importer will print a bunch of IFU's - depending on needs and keep them on stock (until he is made aware of change by manufacturer conform contractual agreement).
Whenever importer receives order where he needs to include translated IFU he will do so.
The questions;
1) importer is not translating IFU, does article 16.2 A applies?
1.1) if yes, how do I need to read 16.4 " Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3."
does this means that importer needs to have a QMS certified by Notified Body?
2) can IFU be provided separately from medical device or does it needs to be included?
Many thanks for your help on this! Any other ideas are welcome (e-IFU is not possible..)