Clinical evaluation without clinical data - MDR Article 61(10)

[RA_QA_Expert]

Hi all,

I would like to ask you for your understanding of Article 61 (10).

When a manufacturer determine, that the demonstration of conformity with general safety and performance requirements based on clinical data is NOT deemed appropriate, it is still neccessary to look for equivalent device?

Clinical evaluation report would contain only why the 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, pre-clinical evaluation, and usability assessment, to be adequate.
Literature research would justify clinical state-of-the-art only. Is that sufficient?

What is your experience? Is anyone willing to share example of such justification?
Thank you

 

[KShaw]

Hi there,

This is a really important question which I was actually thinking about a while back. I believe the justification must be prepared using a risk-based approach, i.e. taking into consideration the risks (severity and likelihood) being posed by the device. Following a risk assessment, should the device be deemed low-risk, I think it is perfectly justifiable to not deem it appropriate to base on clinical data. That said, the clinical evaluation report should still be completed to the expected format (for which, in the absence of specific guidance, I would still use the MEDDEV 2.7/1 rev.4 guidance).

Furthermore, claiming equivalence just for the sake of it has never gone down very well with me. The MDR seems to be very strict about demonstrating equivalence, and so I'm not sure this is the best route to take, although you should definitely perform a sort of equivalence analysis to demonstrate that your device represents the state-of-the-art.

In my opinion, if you are able to prove your claims through non-clinical means and back-up using a risk-based rationale, this would be sufficient for a low-risk device, such as a low-risk class I. If the device has already been placed on the market, you could also further back up your claims through PMS activities.

As Article 61(10) suggests, you should also based you justification on the device interaction and its clinical performance.

 

[Weeder]

My question is regarding devices that do not directly treat or diagnose a disease and do not have a direct therapeutic function - how do you perform clinical evaluation on such devices?

All you can do is test them and ensure they comply to common standards (ISO 134985, etc.), but you are not going to find data on them in clinical papers etc. The regulations do not address this issue.

For example, an MRI machine provides you MR images and that it. It is up to the physician to then read them and determine a course of treatment. The manufacturer has to make sure that the image data is accurate but how do you do a clinical evaluation of such a device?

 

[Raisin picker]

The regulation does address that issue. Check article 61 (1) and especially 61 (10), as KShaw already mentioned above.
"... 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 ...".

Regarding the question on equivalence by RA_QA_Expert: You have to demonstrate equivalence when you want to use (clinical) data of that other device to substantiate your claims. You should only ever bother with equivalence when there is clinical data available for that other device (and you don't have enough own data).

 

[Kuldeep Singh]

We are preparing the Clinical Evaluation report annually for Class IIb medical device., for which we are choosing a professional doctor having clinical experience as an evaluator. During this updation we found there is no major change other than PMS data .Can anyone guide me , Review of updated CER (basicaly due to updation in PMS data) is required involvement of clinical experience evaluator?

Further , Due to updation in CER , can we evaluate the report from evaluator (Doctor in our case) which involve in previous year or a new evaluator is required for updated report?

 

[Raisin picker]

Regarding the second question, you can have the same authors/evaluators every year.

Regarding the first question, there is not only a change in PMS data. Literature search will cover another year, and also search in competent authority databases will cover another year. It can, of course, be the case that these searches did not yield any new data. But still, you can and should document that you performed the searches. And if you tell your evaluator exactly what changed to the report he evaluated the previous year, he should be able to quickly sign the report.
Having said that, there is no requirement to have a professional medical doctor on the CER team. Just someone with knowledge of "diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty)". A medical doctor will fulfil that, but a product manager or similar with several years of expertise in the specific field should be fine as well. Just remember "The manufacturer defines requirements for the evaluators that are in line with the nature of the device under evaluation and its clinical performance and risks." (both quotes from MEDDEV 2.7/1 rev. 4, section 6.4).

 

[Weeder]

We are preparing the Clinical Evaluation report annually for Class IIb medical device., for which we are choosing a professional doctor having clinical experience as an evaluator. During this updation we found there is no major change other than PMS data .Can anyone guide me , Review of updated CER (basicaly due to updation in PMS data) is required involvement of clinical experience evaluator?

Further , Due to updation in CER , can we evaluate the report from evaluator (Doctor in our case) which involve in previous year or a new evaluator is required for updated report?

I don't think you need to update your CER if there is no change in the risk profile of the device. You can file a PMS report and then when it comes time to revise your CER (whatever the established frequency is in your company) then you can update it with any PMS information that you had files away. this also eliminates the need for an evaluator to get involved. I have not seen a requirement for a new evaluator every time you update your CER.

However, I do have a general question. Since you have to pay an evaluator to evaluate the CER (no body is going to do it for free). Will such an evaluation be objective? How do you ensure objectivity. I think more clarification is needed in the regulations.

 

[Lauralfc_]

Hi all,

I have some questions regarding Article 61 (10).

Do you think it only applies to low class devices or could it be applied to devices of class IIa ? Does it required to have a specific standard regarding the device in question ?

Do you have exemples of devices that could fit into this category ? I'm thinking of medical instruments that have technical performances but not really clinical performances...?

Thank you

 

[Raisin picker]

I'm sure it can apply to class IIa devices, maybe even class IIb. One example I know is fridges for blood (how do you call these in english?). They are class IIa (rule 2.2 MDR Annex VIII), but you'd be hard pressed to create any clinical data from patients for them. I've seen installations for medical gases, devices to clean/disinfect/sterilize instruments or other devices.

 

[primavesvera]

What about configurable standalone software with intended use to aid in determination of the suitability of released blood products (crossmatching between the blood product and the patient)?
We perform extensive alpha and beta testing, however, it is purely validation done by the customer, I can't even imagine how to design a clinical study.

Any thought on this?