Clinical Evaluation of very low risk medical devices

Rincewind

Involved In Discussions
#1
I have written Clinical Evaluations using the literature route and so far they have been accepted by the NB.

My question is regarding very low risk devices where there are no clinical literature can be found because no one is performing a clinical study on a surgery table, a scalpel or a plaster. But you would still need a clinical evaluation.

According to MDR Art. 61, paragraph 10:
Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer. In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.

I am assuming this paragraph was written for products like the ones I mentioned earlier.

So I am wondering if the reference to used harmonized standards and a positive Risk-Benefit Conclusion would be enough in general in cases like described above and would you still have to structure the CER according to MEDDEV 2.7/1 rev 4 in that case?

Thank you for any input. :)
 
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Marcelo

Inactive Registered Visitor
#2
Not only use of harmonized standards alone, but there needs to be an rationale of why not using clinical data is deemed appropriate. See also the current MEDDEV 2.7/1 revision 4 item 10.3

One important aspect is that, normally, use of standards can provide basis for rationale for the aspect of clinical performance, but not for clinical benefits (please note that the current MEDDEV uses the term "clinical performance"to include both clinical performance AND clinical benefits, where the MDR solved this problem by creating two separate terms).

Another aspect is that aspect is applicable to the case where clinical data is not deemed applicable to show conformity with ERs, clinical performance, clinical benefit and claims, NOT the case where clinical data is necessary but the manufacturer does not have those.

The real problem, from my experience, is that although these same devices have usually been in the market, clinical data DOES exist, because they have been using the device for years, but the manufacturer has never looked for that. (please remember that clinical data comes from clinical use, not only from clinical investigations, but include information from PMS and any clinical use).

So, for these, clinical data would be applicable, but the manufacturer does not have the existing data (which, note, is different from your comment "there are no clinical literature can be found because no one is performing a clinical study on a surgery table"). They would have to obtain the data for clinical evaluation in some way.
 

FoGia

Involved In Discussions
#4
Hello,


The MEDDEV 2.7/1 rev 4 makes no difference between class I and class III devices. The framework remains the same, the CER will have the same structure for any risk class of device. And by the way, how could you reach a conclusion about risk-benefit profile without performing a clinical evaluation?

Another point: although the regulation aims at demonstrating the clinical benefit of the devices, for a large number of devices you may be able to rely solely on performance data.


My opinion is that no one really knows what is really 'sufficient clinical evidence' for low risk devices because until recently clinical evaluation of such devices didn't get much attention. Only experience will tell how far manufacturers need to go for these types of devices.

As Marcelo points out, yes you will be able to get some clinical data from your existing PMS system (I would imagine mostly data on safety).
 
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