R
Reggie
My understanding of MEDDEV 2.14/2 rev.1 2004 on RUOs is that as they have no medical purpose, CE marking to any of the three directives cannot be applied. My question to the forum is in two parts:
1) Can a validated IVD assay be re-labelled for RUO and sold to customers, as long as it is used for this purpose? What about mis-use?
2) Can RUOs be supplied to customers when the QMS is solely ISO 13485:2016, my thoughts are that they cannot as they have no medical purpose and therefore not medical devices. In which case does the scope of activities involved with RUOs need to be under another QMS like ISO 9001?
p.s. - any solutions on how to provide CE-IVD assays for customers to trial before we register in their country (like Russia) is most welcome.
Best Wishes
Reggie
1) Can a validated IVD assay be re-labelled for RUO and sold to customers, as long as it is used for this purpose? What about mis-use?
2) Can RUOs be supplied to customers when the QMS is solely ISO 13485:2016, my thoughts are that they cannot as they have no medical purpose and therefore not medical devices. In which case does the scope of activities involved with RUOs need to be under another QMS like ISO 9001?
p.s. - any solutions on how to provide CE-IVD assays for customers to trial before we register in their country (like Russia) is most welcome.
Best Wishes
Reggie