Clinical Evaluation - Required Qualification - Class IIa Medical Devices

[pkost]

We do not have an independent expert review. Our evaluations are written by me (where I'm competent) We are a small business and it is impractical to get everything to be reviewed independently. Besides, how can you say that someone you pay/commission is independent? They have an incentive to do a "good" job!

The meddev's are not requirements, just guidelines that is is strongly suggested you follow. A good justification should be sufficient.


I'm being lazy at the moment, so can't quote from the directive, but there is no requirement to carry out the evaluation every year. From what I recall it is just that you should do it as appropriate, or some such wording. In other words, high risk devices should be done more frequently then low risk with which there is a good clinical history. This could mean every month or every couple of years!

 

[craiglab]

The violation is with ISO 13485 4.2.1 "The quality management system documentation shall include (f) any other documentation specified by national or regional regulations." Specified in MEDDEV 2.7.1 r3, under Appendix F (clinical eval checklist for NB, 3.4) "...critical evalution of the literature review... and reviewed and approved by an expert knowledgeable in the “state of the art” and able to demonstrate objectivity."
Agree that this is very difficult to prove, and hard to justify the cost and effort especially since we did not learn anything new from the exercise.
Thanks for your feedback.

 

[pkost]

The thing is though is that MEDDEVs are not regulations....93/42/eec is the regulatory document....meddevs are merely guidance. A nonconformance against 4.2.1 is therefore not appropriate.

to quote from the meddev webpage on the EU site (my emphasis..)

The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives of Competent Authorities pdf - 133 KB [133 KB] and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.

 

[Charlotte Percy]

A problem arises if you claim to comply with a MEDDEV, perhaps in your essential requirements checklist. Then you have left yourself open to a valid finding if you have not followed the MEDEV which you claim you have used to meet the essential requirements of the directive.

 

[Peter Selvey]

My painful experience of EU MDD Annex III testing of high risk devices (dialysis, infusion pumps, including clinical evaluation) led to the conclusion that the extent of clinical evaluation has as much to do with the type of device and intended purpose as it has to do with risk. Unfortunately, auditors using a "one size fits all" (i.e. a checklist form) may not understand this situation.

Some medical devices are designed for a highly specific clinical purpose. In this case, it is usually easy to find supporting clinical data, normally the manufacturer will have access to qualified people for evaluating the clinical data, and access to good quality feedback from real market use.

However, many devices are general purpose (e.g. infusion pump). For such devices, it is up to the clinician to decide the specific mode of use (settings, parameters etc) associated with an individual application. Due to the wide range of clinical uses, it is often very difficult for the manufacturer to comply with regulations (such as MEDDEV 2.7.1 R2) associated clinical data. This includes not only collecting pre- and post-market data, but ensuring qualifications of people reviewing the data.

Logically, for general purpose devices the primary goal is to ensure performance claimed (or implied) is maintained, and this can be largely an engineering issue. It still remains important to monitor literature, and be aware of the difference between bench tests and real clinical application, but persons with engineering qualifications and experience with the device in question should be sufficient, as opposed to a person with clinical experience.

It is noted that the latest edition of MEDDEV 2.7.1 (Rev 3) has watered down the requirements somewhat (possibly due to complaints about the application to general purpose devices), and includes a new statement:

The depth and extent of clinical evaluations should be flexible, not unduly burdensome, and appropriate to the nature, classification, intended use, manufacturer’s claims and risks of the device in question. Therefore, this guidance is not intended to impose specific requirements.

Unfortunately, they then made things worse by adding in the checklist in Appendix F; which of course is not being applied flexibly. Stay tuned, expect this to be changed in the future.

Final point for "craiglab": your auditor made a finding about independence? That is rather surprising. If you read the MEDDEV carefully, independence is a requirement for the NB, not the manufacturer. For the manufacturer, objectivity is the key point, not independence.

 

[antonhoton]

According to definition clinical performance shows evaluation. It should be conducted with individuals. The device quality is an important trait here as my point of view.

 

[MaryFahami]

Hi,

Same with me, background in electronics degree but I have done my clinical evaluation even I didn't have medical background. Quite challenging.
Good luck