Over company is planning on doing a clinical trial on a medical device. We are in the early stages of the product development and don’t have physical devices to complete the clinical trial. We do however know the concept that we wish to trial and one of the options that we are considering is producing devices using commercially available components and accessories, testing them in our lab and routing them for sterilisation prior to conduction the trial. These clinical trial devices will not be visually or physically comparable to the finished device that we are designing, we are using them solely to prove out the clinical concept. Is this a legitimate approach and will it be accepted by the Competent Authority and Ethics Committee. Appreciate any guidance that you can provide.
Clinical Trial using Prototype devices (EU MDR & ISO 14155)
- Thread starter Chitchat
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It is legitimate for a proof of concept, but you will not be able to use it as part of a regulatory submission.
The competent authority and ethics committee will review what you submit for a trial; they have no way of knowing what the commercial product will look like, and neither do you
These authorities want to be assured that the device is safe and is able to do what it is intended to do.
The competent authority and ethics committee will review what you submit for a trial; they have no way of knowing what the commercial product will look like, and neither do you
These authorities want to be assured that the device is safe and is able to do what it is intended to do.
Raisin picker
Quite Involved in Discussions
You should be aware of the difference between exploratory trial and confirmatory trial. For the former, your approch should work. For the latter, which you use for CE submission, you will need a very good justification not to use the final device.
Read and understand the concept of clinical data (MDR Art. 2 (48)) and equivalence (Art. 61 and Annex XIV (3)). This might give you an idea if your approach has any chance of success.
By the way, your question is missing the most important information: what type of device are we talking about? A class III implantable, or a class Ir instrument?
Read and understand the concept of clinical data (MDR Art. 2 (48)) and equivalence (Art. 61 and Annex XIV (3)). This might give you an idea if your approach has any chance of success.
By the way, your question is missing the most important information: what type of device are we talking about? A class III implantable, or a class Ir instrument?
I have a follow-up question to above:-
The trial that we will be conducting will be an Exploratory / Early Feasibility Clinical Investigation to evaluate a design concept for a clinical performance of the device. Given this, do we need to comply with all of the requirements of ISO 14155?
In particular 6.10 Labelling “The investigational device, the instructions for use, or the packaging shall indicate that the investigational device is exclusively for use in a clinical investigation, unless this is not required (see I.7)”, specifically “NOTE See ISO 15223‑1 and national or regional regulations for further information on labelling.” or can we claim an exemption from this requirement and note it in the CIP?
I.7 a) “Pre-market exploratory clinical investigation: all principles in this document apply with the exception that no mandatory (pre-)specification of a statistical hypothesis is required.” Would suggest differently?
Thanks for your help and guidance!
The trial that we will be conducting will be an Exploratory / Early Feasibility Clinical Investigation to evaluate a design concept for a clinical performance of the device. Given this, do we need to comply with all of the requirements of ISO 14155?
In particular 6.10 Labelling “The investigational device, the instructions for use, or the packaging shall indicate that the investigational device is exclusively for use in a clinical investigation, unless this is not required (see I.7)”, specifically “NOTE See ISO 15223‑1 and national or regional regulations for further information on labelling.” or can we claim an exemption from this requirement and note it in the CIP?
I.7 a) “Pre-market exploratory clinical investigation: all principles in this document apply with the exception that no mandatory (pre-)specification of a statistical hypothesis is required.” Would suggest differently?
Thanks for your help and guidance!
