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Is there a need for clinical test of Class IIa products (for MDR)?

#1
Hello

We are preparing for MDR of crown resin (Class IIa for dental Material).

In clinical evaluation, we are not conducting a clinical investigation in accordance with MDR's''Article 61.4 & Article 61.6, but trying to compose a clinical evaluation report with and the tests(Physical,chemical and biological stability test) and the results of the literature search according to equivalence.(Similar product license in MDD)

Article 61.4:
In the case of implantable devices and class III devices, clinical investigations shall be performed, except if: In addition, clinical investigations need not be performed in the cases referred to in paragraph 6.

Article 61.6:
The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices and class III devices: (b) that are sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such a CS is available.


In this regard, we ask for your opinion whether it is better to proceed without conducting clinical investigations using actual products, or whether it is better to proceed without conducting clinical investigations outside of Europe. (Headquarters are located in East Asian countries.)

Thank you
 
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yodon

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#3
I'm guessing the lack of response is because you're in a specialized / gray area. Have you had a chat with your NB and asked them if they see any issues with the approach? "Better" is going to be their call, anyway. You can't ask what the best approach is since a response would be consulting. Maybe they'll respond if you lay out your approach (with rationale) and see if they disagree. They may still not want to answer but it's worth a shot.
 
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