Trial of New Medical Device

JoCam

Trusted Information Resource
#1
Hi All,

During early stage development of a class I medical device, when it becomes necessary to establish whether the concept will actually be beneficial to the end user, what would a trial performed using patients be referred to as, and how should it be controlled? The device in question is a development on an existing class I device, and the changes superficial, having no affect on the safety of either the patient or health care provider.

Jo
 
Elsmar Forum Sponsor

rob73

looking for answers
#2
What you are describing sound like a clinical investigation, from MEDDEV 2.7.2 rev 4:

Clinical investigation: systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device.
Clinical investigations are carried out to EN ISO 14155:2011, guidance can also be found in other MEDDEV's see http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

If this device is based on an existing device then a clinical evaluation may suffice

Clinical evaluation: a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.
 

shimonv

Trusted Information Resource
#3
Hi JoCam,
You mentioned that its a class I device, meaning a low risk device.
You also mentioned that its superficial changes on top of an existing device.

It sounds like an engineering change (a revision change) that does not require investigation. I believe that a rationale explaining why no validation is required or a small usability study on simulated environment will suffice.

Shimon
 

dgrainger

Trusted Information Resource
#4
ER 1 requires that you have looked at risk & benefit.
It sounds like your trial is a clinical investigation to demonstrate ER1.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
In my opinion it depends on what you are going to test.

If it's the performance of the device then it falls in the domain of clinical investigation (trial) / evaluation.

If it's the way end users understand it and apply it, it's more likely to be a usability study - you could refer to either IEC 62366 of FDA guidance as applicable.

The question of whether you need a clinical investigation or just a theoretical evaluation (under the first scenario) depends on the novelty and amount of documented experience already available to you.

What do your internal QMS procedures say about existing devices modifications?
 
J

Julie O

#6
Given that you posted in the EU sub-forum, I take it that you are asking about what is required for CE marking.

Design validation is a design control under ISO 13485. I can't help you much there, except to note that 7.3.7 of ISO 13485 (2016) refers to a need for clinical evaluation, which isn't necessarily the same thing as a clinical investigation/clinical trial.

The MDD requires a clinical evaluation, which, again, isn't necessarily the same thing as a clinical investigation/clinical trial. MEDDEV 2.7/1 Revision 4 provides detailed guidance on clinical evaluations:

http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

 
Last edited by a moderator:
J

Julie O

#7
I'm also a little confused by "early stage" and "concept."

If you are talking about a clinical trial for design validation, that's the last thing you would do before transferring the design to manufacturing, which I would consider to be well past the concept stage. Unless maybe you are talking about a prototype to be used for "proof of concept."

Usually I think of the "early stage" effort to establish usefulness of the concept to users as the development of user requirements under ISO 13485 7.2.1.
 

JoCam

Trusted Information Resource
#8
Hi JulieO,

I know what is expected to gain the CE mark, and we have started to compile the Design History File. We would like to trial the product using patients mainly to establish if the product is feasible, therefore it does fall into the feasibility study phase and the exercise could probably be termed a usability study. However, because patients are involved I want to establish whether or not we need to request a 'Notice of No Objection' from the CA before the study can commence.

I'm guessing, being as the changes are mainly superficial and that the system will still be used within its intended purpose, that I can justify not having to do this.

Jo
 
J

Julie O

#9
Understood.

I'm afraid I can't help you with this, but I will post your question in the RAPS forum; perhaps someone there has experience with this.
 
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