Clinical evaluation for legacy device

Junn1992

Quite Involved in Discussions
Hmm...well post market data dosen't quite cut it as clinical data under the MDR, because it was not obtained under clinical trial conditions which are well controlled, and have proper statistical analysis where you know for sure the sample size.

Please read carefully section 6.5(e) of MDCG 2020-6 and definition of well-established technologies. I believe all the answers are there, and it is difficult to give a concrete answer on this issue via forum.

HTH
 

Raisin picker

Quite Involved in Discussions
You can always try to argue "that there would be no clinically significant difference in the safety and clinical performance of the device" (MDR Annex XIV) due to the difference in composition. For the justification, read MDCG 2020-5, section 3.2 and try to argue along these lines. Remember that "Considerations of equivalence shall be based on proper scientific justification."
Basically the last option you described.
Maybe write this up in a small document and ask your NB if this would be acceptable.
 

boncki

Registered
Thank you for the advice :)
MDR says there is a not exhaustive (but closed for now) list of technologies that can be recognised as WET. On the other hand, MDCG says that there are 4 criteria and "any devices that meet all these criteria may be conseidered well-established technologies". What do you think about this rift between the MDR and MDCG 2020-6 on the definition of well-established technologies?
 

Raisin picker

Quite Involved in Discussions
Do NOT ask about differences in interpretation between MDR and MDCG. The more closely you analyse that, the more holes you see ;-)

Again, here you could argue that the WET list in the MDR is specific for implantable devices and does not cover the majority of devices, which is IIa/IIb non-implantable (ignoring the class I devices where the CER is not submitted to the NB). And those WET definitions are applicable in specific situations only, not for clinical evaluation in general.
I've seen the WET definition being successfully applied to IIa devices, although an exhaustive justification along the definitions of MDCG 2020-6 was required.
 

FoGia

Involved In Discussions
Do NOT ask about differences in interpretation between MDR and MDCG. The more closely you analyse that, the more holes you see ;-)

Again, here you could argue that the WET list in the MDR is specific for implantable devices and does not cover the majority of devices, which is IIa/IIb non-implantable (ignoring the class I devices where the CER is not submitted to the NB). And those WET definitions are applicable in specific situations only, not for clinical evaluation in general.
I've seen the WET definition being successfully applied to IIa devices, although an exhaustive justification along the definitions of MDCG 2020-6 was required.
Actually in this particular case it is fair to raise the differences because there is one huge (repeated) typo in the MDCG 2020-6: the guidance actually refers to "standard of care" devices and not the WET devices described in the MDR and serve as a guide in the assessment of the required level of evidence of these former devices. Although not officialized, this is the position of the BSI, and they claim that there is agreement at Team-NB level on this topic. Source: Webinar series: clinical evaluation masterclass on demand webinars
 
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