Medical Device Clinical Evaluations - How often are Clinical Evaluations required?

F

FEYBASS

#1
I work for a medical device manufacturer, and I'm in teh process of updating our Technical Files to comply with 2007\42\EEC. I know that I have read somewhere that a review of Clinical Evaluations need to be performed at least annually, but I cannot find that reference. Also, is there a similar "perform annually" reference for Risk Analysis review and/or Post Market Surveillance review?

Thanks for your help!
 
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Sam Lazzara

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#2
Re: Clinical Evaluations - how often?

MDD Annex X, section 1.1.c states:
"The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented."

No mention of a specific frequency in the MDD and I do not believe a frequency is recommended in the applicable guidance document (MEDDEV 2.7.1, Rev 3)? It states the following in section 6.2: "Post market surveillance reports are compiled by the manufacturer and often include details of the device’s regulatory status (countries in which the device is marketed and date of commencement of supply), regulatory actions undertaken during the reporting period (e.g. recalls, notifications), a tabulation of adverse events (particularly serious events and deaths, stratified into whether the manufacturer considers them to be device-related or not) and estimates of the incidence of adverse events. Post-marketing data about adverse events are generally more meaningful when related to usage but caution is needed because the extent of reporting may vary considerably between countries. The analyses of data within these reports may, for some devices, provide reasonable assurance of both clinical safety and performance."

In my personal opinion, you could provide your updated clinical evaluation experience in an annual Post Market Surveillance Report. I think an annual frequency would be accepted by (most) Notified Bodies.

I have attached both documents referenced above.
 

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F

FEYBASS

#3
Re: Clinical Evaluations - how often?

Thanks, Sam. I had the current MDD version, but didn't have the Clinical Evaluations guidance document. Very helpful. And good to know that the Post Market Surveillance procedure is where the Clinical Evaluation piece can comfortably reside (we were thinking of housing it in the Technical File procedure, but that didn't really make much sense to me). So thanks for shedding more light on the subject for me :)
 
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