Research use only MEDICAL DEVICES IN EU

[RegulatoryUS_EU]

Hi all,

hope you're doing well.

I wanted to ask you a question related to Research use Only regualtory status in the EU

My understanding is that RUO, in EU, can only be applied in the EU for IVD products and following strict restrictions on claims

For MD, my understanding is tht, there is no RUO legal figure in the EU. Is this correct? I've heard a lot of times comapnies that say "I am going to sell my device to hospitals and research centers as a RUO device" but my understanding is that this, in principle,is not legally possible

the only option will be that the MD is used as part of a clinical trial and thus labelled as an "investigational device" but this is not the same as RUO, from my understanding. is this correct?

hope you could help us!
best
J

 

[Orca1]

Your understanding is largely correct. In the EU, the concept of "Research Use Only" (RUO) is not a recognized regulatory status for medical devices. The term is more commonly associated with IVD products, which are used for testing in laboratories and not on humans.

For medical devices, if a product is intended to be used for a medical purpose and falls under the definition of a medical device according to the MDR or IVDR, it must comply with the relevant regulations, regardless of whether it is used in a research setting or not.

If a device is used as part of a clinical trial, it is indeed considered an "investigational device" and not a RUO device. The clinical trial sponsor assumes the obligations incumbent on manufacturers according to Article 16(1) of the IVDR (MDCG 2022-10, Page 13, Paragraph 2).

 

[RegulatoryUS_EU]

thank you orca so much!