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MDCG 2020-06 Clinical evidence legacy devices

Chrisx

Involved In Discussions
#1
New guidance came out regarding clinical evidence for legacy devices. Currently, most of our products are implants and would be well-established technologies. Unfortunately, we have no clinical studies on our own devices. We will be starting PMCF studies, but it will take some time to get results. Anyone have any thoughts on the chances of MDR approval with only complaints, vigilance, information on similar devices and a very limited number (like 3) of basic surveys to surgeons? I'm worried we may not gain approval until the PMCF studies are completed.

Thanks!
 
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yodon

Staff member
Super Moderator
#2
First off, just to be sure, you're referring to this guidance?

You *never* did any clinical studies for an implantable?

The whole idea (in general ... and I think I have this right) is to continually assess your device for safety and effectiveness. You do say you have some "clinical data" in the complaints, vigilance, etc. I don't think they're saying that a PMCF study is REQUIRED if you can adequately demonstrate safety and efficacy (and compliance to relevant GSPRs)

You ask about your chances for MDR approval with just complaints, vigilance, etc. According to the guidance, you at least need a Plan (there's a pretty specific bullet list in the guidance) and an appraisal of the data. You'll also, of course, need to demonstrate compliance to relevant GSPRs.
 

Chrisx

Involved In Discussions
#3
Thanks for the advice. Yes, I was referring to that guidance. Unfortunately, most of our implants are CE marked without clinical studies. Unfortunately, I don't think this is that unusual.
 

Raisin picker

Involved In Discussions
#4
Sorry if that sounds harsh: The MDR has been released 2017, MEDDEV 2.7/1 (rev. 4) 2016. Drafts have been available for longer. Ample time to do some cheap (relatively speaking) PMCF trials and other PMCF activities to collect data. You still have a few months now ...

And yes, you're not alone. But quite a number of manufacturers finally listened to their NB and started to do some more PMCF.

On the other hand, if your devices are already approved under MDD or are actually well-established technologies as defined by the MDR (such as sutures, screws or nails as listed in Article 61(6b)), you are not forced to have genuine clinical trial data. But you should still try to collect as much clinical data as possible via PMCF (questionnaires to power users, surgery report from your technical staff, ...), since your CER needs to be based on sufficient clinical data.

Have good PMCF trial plans ready, show that you already started the trials, present interim data as available, and hope for the best. Explain in detail why the data you have currently is sufficient. Section 5 of MDCG 2020-6 gives you some hints what aspects your justification has to cover.
 
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