Clinical Affairs

This is a place to discuss all your clinical investigation requirements and use cases.

  • 5 Topics
  • 11 Replies

5 Topics

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Silvia RonchiNew Participant
asked in Clinical Affairs

Combined Trial

Dear all, do you have experience with combined trial (where the object of the evaluation is 2 different products: a drug and a medical device)? Are 2 different protocols required? In which way the 2 submissions are linked and how the 2 different regulatory authorities communicate the outcome of the 2 applications, do we need 2 different approvals?Thank you very much,Silvia Ronchi 

4
S
21 days ago
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Silvia RonchiNew Participant
asked in Clinical Affairs

LDT under the IVDR

Hello, do you have experience with LTD assay developed and used in the US to test samples from EU patients enrolled in a clinical trial?My understanding is that this is not “distance sales” (IVDR art. 5) because the assay is not used for remuneration in a commercial activity, but only for a clinical trial. And this is not an “in-house” test, because IVDR art. 6 applies only to EU laboratories.So, a LDT developed and used in the U, to test samples from EU citizens for a clinical trial, is not subjected to the IVDR requirements?Thanks for your advice. 

3
E
3 months ago
joningib
joningibEmployee
posted in Clinical Affairs

Overview of Medical Device clinical activities - updated table from ISO 14155:2020 Annex I

Hi everyone.I posted this on LinkedIn earlier today. I thought you might find this interesting as well.The table below is an updated version of a table presented in ISO 14155:2020, Annex I. I felt there were a few descriptors and additions missing, so I created my own version.In my experience, people tend to only use "descriptors" when talking about medical device clinical activities - which can be confusing if you don't follow the same terminology standard.Descriptors can vary from one country, or regulatory environment, to another. But most importantly, descriptors are only one attribute of many️, used to describe a clinical activity. Only when all attributes are put together you can fully identify a clinical activity.The pilot stage is a good example, where people tend to use different descriptors for the same clinical activity.There are also a number of study designs that could be included in this table. But for the lack of more advanced design skills, and for the sake of my sanity

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joningib
3 months ago
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MCZNew Participant
posted in Clinical Affairs

Implantation

Hi All, We are designing our strategy to get our device to a pilot clinical trail and when discussing biocompatibility testing with an expert in the US, he told us our chronic animal study should be at least 90 days and GLP in order to meet the implantation safety requirements to get the green light for our pilot.  Does anyone has any experience that can share?Our pilot will be conducted in Europe, specifically in Germany and Italy.  And our original ideal was to do chronic implantation for 10 weeks in a non-GLP animal study, do we really need to have 90 days of implantation? Thanks!  

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joningib
5 months ago
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sandra.veenstraNew Participant
asked in Clinical Affairs

ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice 

Hi everyone, I had a follow up question from the AMA last week w/ Smart Trial. One major takeaway I had was reference to the ISO standard 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice as the gold standard in addition to ICH-GCP. However, the standard specifically states that "[it] does not apply to in vitro diagnostic medical devices." Wondering if anyone is aware of an equivalent standard for in vitro diagnostic medical devices ? Or what standards, beyond compliance to ICH-GCP, others are adhering to.  @joningib 

1
joningib
7 months ago

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