Device Registration Terminology in EUDAMED

[AngelRose]

Hi guys!
I'm fairly new to the regulatory field and was recently asked to start registering our Basic UDI-DIs and eventually the single UDI-DIs for different models of the family of devices.

I wanted your opinion/interpretation of some of the information I'm required to enter as to avoid making false declarations.
1.) Professional Testing - Unfortunately I'm unable to find an exact definition of what professional testing means. I assume it means that the device is used by a trained professional and that it intends on quantifying something and providing a diagnostic result. I'd like to hear your interpretation on this.
2.) Is the device directly marked? - The UDI system has yet to be implemented on our company, but we plan on voluntarily adding UDI DataMatrix/Barcodes on the labels of our products (even though we're still not required to). Do I have to select "No" to this section and change accordingly once we do?
3.) Is the device designed and manufactured by another legal or natural person? - Some of our devices are designed by and manufactured in another country outside of the EU: we change some components and market said device under our name and trademark. Assuming we're still compliant to RUE 2017/746 in regards to manufacturer obligations, do we still have to declare the information of the original manufacturer?

I'm also perplexed as to when and where UDIs (UDI-DI + UDI-PI) are supposed to be declared. Can someone kindly clarify?
Thank you in advance!

 

[yodon]

We may need some more context for these. I can make a _guess_ on the first one:

1.) Professional Testing - Unfortunately I'm unable to find an exact definition of what professional testing means. I assume it means that the device is used by a trained professional and that it intends on quantifying something and providing a diagnostic result. I'd like to hear your interpretation on this.

On the surface, I would think this would be for testing like biocompatibility and 60601-1 testing. Generally, those are done by (accredited) test labs since they require equipment most companies don't have. I don't think it would be related to use / users of the device.

 

[AngelRose]

Sorry for the late reply,

I apologize for being vague and reductive. I'll try my best to contextualize the situation at hand.
Our company is EU-based and we manufacture low-risk devices for general laboratory use, intended to be used for in-vitro diagnostic procedures; therefore, our devices fall under the scope of IVDR (EU Regulation 2017/746) and are classified as Class A. The obligation for placing the UDI-carriers on the labels of our devices starts from 26th May 2027. We've providently decided to voluntarily comply with the requirements despite this deadline, so we're starting to implement the UDI system.

My questions arose from filling the EUDAMED "Basic UDI-DI Registration Module" and wanted your professional opinion or interpretation regarding the information I'm required to enter to guarantee the highest accuracy in our applications.

 

[akp060]

Is the device directly marked?

Please see Section 4.10, Part C, Annex VI of the EU IVDR 2017/745. That's what being asked there

 

[AngelRose]

Thank you @akp060 and @yodon for your inputs. I appreciate your help!
I did my due diligence and reread the Regulations to find some answers. This is the conclusion I came to:
1.) Professional Testing - as yodon pointed out, it does refer to devices which conformity assessment involves reference laboratories designated in accordance with Article 100 of the IVDR.
2.) Is the device directly marked? - as akp060 pointed out, it refers to reusable devices that require disinfection, sterilisation or refurbishing between patient uses.
3.) Is the device designed and manufactured by another legal or natural person? - The simple answer is yes in accordance to Point 14, Article 10 of the IVDR.
4.) When and where UDI needs to be registered? It is not subject to registration since the information it contains is variable. The codes declared (the device's UDI-DI, the composition of its UDI-PI and its Basic UDI-DI) is exhaustive enough for traceability purposes.