Clinical Evaluation - Required Qualification - Class IIa Medical Devices

[DangerousDave]

Hi All

I have recently taken over as Reg Affairs person in a small electronics company where my predecessor has done no work on updating technical files for several years, and now I am in a position to get them up to date pretty pronto (especially as 2007 MDD comes into effect in March). We manufacture class IIa medical devices.

My predecessor "claimed" that she was "allowed" to generate clinical evaluations for technical files as she had a medical degree, and someone like myself wouldn't as I do not have a medical degree (electronic engineering is my background). Is this the case?

I have seen several examples of how to do a clinical evaluation on a class II device on the forum, and in the same way many of these are, we have had most of our products on the market for many many years with no incidents, and our retrospective clinical evaluations would be based on this.

Any advice greatly appreciated.

Dave

 

[SteveK]

Re: Clinical Evaluation - Required Qualification

Hi Dave,

If you have looked through the forum you may have come across “Clinical Evaluation” at https://www.ghtf.org/documents/sg5/sg5_n2r8_2007final.pdf.

This defines:
Who should perform the clinical evaluation?
The clinical evaluation should be conducted by a suitably qualified individual or individuals. A
manufacturer must be able to justify the choice of the evaluator(s) through reference to
qualifications and documented experience.
As a general principle, evaluators should possess knowledge of the following:
• the device technology and its application;
• research methodology (clinical investigation design and biostatistics); and
• diagnosis and management of the conditions intended to be treated or diagnosed by the
device.

In my case I have conducted clinical evaluations via the literature route i.e. comparison devices (class IIa & IIb). I have reviewed the information both positive and negative (e.g. device alerts) and have put together a report citing the references and including abstracts etc. It is partly a risk assessment too, i.e. what are the hazards, how long have similar devices to your own been on the market – safety record.

The above is for guidance and I do not think points 2 & 3 should be rigidly applied – conducting clinical trials and writing their protocols is a very specialist area – so is biostatistics. The third point does suggest a medic – but who (especially in a small company) is likely to be such a polymath if you include the device technology as well.
I am a Chemist/Polymer Scientist (degrees) and not a medic, but have been dealing with medical devices of various types for 30 years. The last auditor was OK with my approach and ability. I think it is the ability to evaluate information that is the key as well as understanding the product area – which as an electronics engineer evaluating electronic devices seems fine to me. Maybe a word with you NB may put your mind at rest. I hope this helps.

Steve

 

[DangerousDave]

Thanks Steve

I did find that document, but nowhere is it defined (that I could find anyway) what "suitably qualified" means. I am guessing that is down to us to justify the person who is performing the clinical evaluation!.

From what you say though, I can perform a clinical evaluation based on the technological aspect of a device, but if it had physiological effects, this would have to fall to someone with a medical background.

Your advice is very useful though. Thanks once again.

Dave

 

[bio_subbu]

This topic is covered in ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects part 1 General Requirements) point no 6.2 Qualification. The standard says that “All parties participating in the conduct of the clinical investigation shall be appropriately qualified by education and/or experience to perform their tasks”. My suggestion is, if you have any experience in conducting clinical evaluations, get the revised Job description and approved from your immediate reporting manager/Boss and also keep if any training proof on clinical evaluation in your Personnel training file.

 

[SteveK]

I think I have tried to point out the difference between 'clinical evaluation' and 'clinical investigation' before in the cove. The latter is a totally different animal - it means conducting 'clinical trials' i.e. involving medics, CRAs, Declaration of Helsinki, trial protocols, ethics, sponsors etc etc. I know ISO 14155-1 mentions 'critical evaluation of the litereature - Annex A.2.5', but because of what I've indicated in the requirements, I would expect this to be conducted by clinical trial specialists as per clause 6.2.

Steve

 

[Burgmeister]

I guess we are quite lucky in that we have a 'pet' surgeon who is very amaible to requests from us. He was the first surgeon to use our product back in teh early 90s. We conducted the analysis from a technical point of view and then asked for his written comments about the reports from a medical point of view. We also included a little resume on the surgeon to show his experience and suitability to comment. This appears to have satisfied the auditor as we were reviewed against the updated MDD in December, however, I suppose a different auditor may see things differently.

 

[medwise]

Dear All,

How often do we have to revise the clinical evaluation? Is there any requirement to review it every few years or so like other quality documents as per ISO 13485:2003?

If we have to define the period then is 3 years ok?

Thanks
Romit

 

[SteveK]

Dear All,

How often do we have to revise the clinical evaluation? Is there any requirement to review it every few years or so like other quality documents as per ISO 13485:2003?

If we have to define the period then is 3 years ok?

Thanks
Romit

Hi Romit,

My take on this is that clinical evaluation is part of the overall post market surveillance requirement. So I would expect a review between audits i.e. at least annually. This is only my opinion.

Steve

 

[pkost]

I determine how regularly to carry out an evaluation based on the risk of the product. My NB seems happy for me to do this.

For instance, a class III device that we recently introduced has little market history so I have stated in my previous evaluation that I will carry out another in at least a year or before if any pertinent information comes to my attention

we also have a class IIb product which has been on the market for close to 50 years, it is well matured and it is very unlikely that anything new is going to appear from any evaluation - I therefore stated in my last evaluation that I would carry out the next one in 3 years so that it happens within an NB review cycle

There is a requirement to review regularly, but as "regular" is not defined then it is what you can justify....It seems sensible to me to use a risk based approach

 

[craiglab]

Besides being qualified to write the report, how have people handled independent expert review (evaluator) as per MEDDEV 2.7.1 (9)? This was a finding during our last audit and the auditor said he sees this all the time. So we need a non-customer, physician, non-disclosure... It was implied this should be done yearly even though we have a postmarket surveillance process that looks at the same inputs and feeds the risk analysis. Clin eval via literature review route.