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


Starting to get Involved
@Reggie - Under the directives, it is a known approach to sell RUO devices that are validated by laboratories and used for medical purposes. This seems to be a bit of a grey zone and it is a thorn in the flesh of the regulators. Therefore, they tried to exclude this option within the regulation 746/2017.

I am not an expert for Russia, but regarding the Union, you can invoke article 4 of 98/79. Just mark them as demonstration only and of course the assays must not be used on patients (or specimens taken of patients).

Regarding 2) A lot of suppliers are manufacturing under their 13485:2016 certificate without creating a CE-marked medical device. If you decide to produce RUO devices with the processes of your QMS, I do not see an issue.
@L_O_B - Thanks for the feedback on the directive and i can understand article 4 would help for demonstration purpose. I guess i have always been worried that manufacture of RUOs is a bit out of our 13485 scope and so wouldnt look good during our audits, as RUOs have no medical purpose. For this reason we used to have ISO 9001 for the RUOs, but this has now lapsed.

If as you say it is a known approach, do you think an auditing body would accept this or not?

Best Wishes

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