An auditor asked for a Post Market Surveillance Report

[SpartanBio]

I recently had an auditor that asked for a Post Market Surveillance Report, this is not something I had experienced before.

We include post market surveillance as part of our management review. Does anyone else have experience with this?

If so what do you do? I can't find anything when I search the mighty Google regarding the requirement for a report, just that we need to do it and we do.

Thanks
Keri

 

[Al Rosen]

I recently had an auditor that asked for a Post Market Surveillance Report, this is not something I had experienced before.

We include post market surveillance as part of our management review. Does anyone else have experience with this?

If so what do you do? I can't find anything when I search the mighty Google regarding the requirement for a report, just that we need to do it and we do.

Thanks
Keri

Print out a report from your complaint database.

 

[yodon]

I would tread pretty carefully here. There are several things to consider. First, this is posted under the 14971 topic. Certainly, 14971 DOES have provisions for collecting information and reviewing for impact on the risk analysis (see section 9). They do talk about updating the Risk File so it may not be what the auditor is after. If you provide a complaints report without closing the loop on the risk analysis, you could be rather exposed.

The MDR (for which you can't yet be held to) spells out very well that a PMS Plan and Report are required. This is clearly the expected direction to be heading but if this is the basis for the finding, they may be overstepping.

While the PMS report doesn't seem to be specifically indicated by the MDD, there may be something in a country-specific requirement that drives it. Or maybe your internal procedures (which I presume you've already ruled out). I would ask the auditor what the basis of the finding is ("what's the requirement") and frame the response around that.

 

[Marcelo]

The Post Market Surveillance Report is a new requirement of the MDR

Article 80
Post-market surveillance report
Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the notified body and the competent authority upon request.

So, this is related to all the data you gather, with passive and active sources.

For more information on this, please wait for publication of ISO TR 20416
Medical devices -- Post-market surveillance for manufacturers, or read the n numerous guides on PMS (GHTF, MEDDEV, NB-MED).

 

[pavel]

Good day, colleagues.
Is there any information or predictions when it will be published ISO TR 20416 ?
In site ISO done only 20% !