Hello all,

my question might be more regulatory that quality but many of us do wear both caps.
We are considering distributing, in Europe, in vitro products manufactured by an other company. While checking their product list I saw that some products were bearing at the same time a nice CE mark and a sentence stating "For Research use Only". When asked the guys replied they labelled their products so, because they do not have the performance evaluation results yet. So no diagnostic use can be claimed, but as they manufacture them under a Quality System, CE marking is affixed.
I understand that they tried to set-up an ASR-like status for their products in Europe.
But in my reading of the 98/79/EC directive this case of falls under chapter 17 of the Directive as wrongly affixed CE marking.
Any one to help me on this one ?

Vincent,

This does sound like it is a case of wrongly affixing the CE marking, however they may be considering the RUO devices as "adapted".

You may want to ask a few more questions:
1. How do they classify a device as RUO?
2. Are they considering this device to be adapted?
3. How/where is the RUO device being used?


Good luck!

Dear Vincent,

which products are these (List A, List B, general)?

It is possible to follow Annex VIII (performance evaluation), but note
(8) Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation;

A CE-mark on a product is always a proof of conformity. So any CE-marked IVD product MUST comply with 98/79/EC.

Article 18.2 says:The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.

Manufacturers who have not reached compliance sell their products as RUO, but in this case it is not allowed tu use them for diagnostic purpose.

A product for research use only which has no medical purpose, cannot be a medical device and, therefore, cannot be an IVD medical device. By definition, these products fall outside the scope of the IVDD and the other medical devices directives.

Article 8 of Directive 98/79/EC states:
Whereas instruments, apparatus, appliances, materials or other articles, including software, which are intended to be used for research purposes, without any medical objective, are not regarded as devices for performance evaluation.

This means, that "RUO products", which have no "official" medical indication and are not yet established in medical diagnosis (i.e.not finished clinical trials), are excluded from the scope of the directive and must not be CE marked.

This topic has been discussed in several expert group meetings, a MEDDEV should be issued within time.

And: there was an accident in an european county with RUO IVDs: A RUO HIV-Test was used for diagnostical testing and delivered false negative results.

In my opinion CE and RUO marking exclude each other.

~ghw

I suppose a bit late, but your device is a reagent or a electric powered device? For electric powered ones, a CE mark can be affixed just for electric security directives, and at same time, intended to research tasks. In my companys, i manage some of this products (v.g., image capturing microscopes).