Clinical evaluation report for class I device

shimonv

Trusted Information Resource
#1
Hi Fellows,
A company that I work for has a class I medical device which is in commercial use for several years. They now need to make the adjustments for MDR.
One of the MDR requirements, which is my opinion is a waste of time, is a clinical evaluation report according to MEDDEV 2.7/1 revision 4. It's a big task which is usually outsourced and quite expensive.
Does anyone have ideas or experience on how to work around this? Perhaps some rationale / memo to file.

Thanks,
Shimon
 
Elsmar Forum Sponsor
#2
I'm far from being an expert in regulatory affairs, but my company is in the same situation as you (low-risk class I device that has been on the market for many years). We hired a consulting firm to help us with the MDR transition and they suggested we write a justification for exemption under Article 61, section 10, which states "...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".

It was suggested that we write up something that talks about how we are a low risk device (reference risk assessment checklist) and that (in our case) the device does not interact directly with the human body. Possibly elaborate on how the device has been in use for many years and how we use non-clinical methods, such as performance evaluation, post-market feedback, ongoing testing, etc. to ensure a safe and effective product.

I don't know yet if this will be acceptable by our EU AR, but that is how we are planning to handle this.
 

Raisin picker

Involved In Discussions
#3
Article 61 (10) is a good idea, which is overlooked too often (a similar exemption was included in MDD, Annex X, 1.1d). You should be aware that you still need a clinical evaluation report, just without clinical data.
You should shall make use of Article 61 (1), second paragraph ("specify and justify the level of clinical evidence necessary"), if section 10 is not an option.
 

shimonv

Trusted Information Resource
#4
Thank you both!
Very good insights. I suspect that a justification that resembles a clinical evaluation report, just without the clinical data has a better chance to pass the EU rep.

Shimon
 

JP12345

Starting to get Involved
#5
Further to this discussion, does anybody know if PMCF is still required for those devices where Article 61, section 10 is used? Thank you!
 

Philip B

Involved In Discussions
#7
I don't think there is an easy way around CERs, they need to meet MEDDEV 2.7/1 irrespective of device classification. We carried out a literature search and collated other data (outputs from risk management, complaints, incidents, results from PMS etc) and wrote it up using the identify, appraise and analyse structure. As others have said you can exclude clinical investigations / PMCF if there are no residual clinical risks that require investigation. But even our simplified approach took me, at a guess, 20-30 hours or so.
 

JP12345

Starting to get Involved
#8
Thanks both, that has been very helpful. So it seems like if there are no residual clinical risks to follow up, we provide this justification in the clinical evaluation?
 

Raisin picker

Involved In Discussions
#9
Well, be careful there. First, the justification should (also) appear in the PMS plan, since PMCF is part of PMS. Then, PMCF is not limited to PMCF studies (popular misconception). There are a number of other possible activities in this area that require small effort and small money only. Check Annex XIV (5) and (6), especially (6.1):
6.1. The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of:
(a) confirming the safety and performance of the device throughout its expected lifetime,
(b) identifying previously unknown side-effects and monitoring the identified side-effects and contraindications,
(c) identifying and analysing emergent risks on the basis of factual evidence,
(d) ensuring the continued acceptability of the benefit-risk ratio referred to in Sections 1 and 9 of Annex I, and
(e) identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
(emphasis by me)
If your justification for Art. 61 (10) is accepted, a similar justification should also work for all of PMCF. To be sure, I'd cover all 5 topics above and demonstrate why there is no PMCF necessary for each.
But if it is not accepted, be aware that PMCF can contain a number of tasks that you perform actively (as opposed to collecting complaints and the like). This could be as simple as specific questionnaires to a defined set of users, and of course research in competent authority databases and literature databases.
 

Philip B

Involved In Discussions
#10
Yes, document it in the CER and also in your PMS plan. A good way to do this is to take the reasons for doing PMCF (from MEDDEV 2.12/2) and reverse them ( an idea I got from this forum).
 
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