Post-Market Surveillance required by the EU's MDD vs. ISO 13485 Requirements

S

SteveK

#11
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

As Al and I (and the MDD) have indicated, the post-market surveillance is for your own products. I think the problem is that, other than anecdotal evidence (e.g. from sales staff, medical device related forums etc), how difficult it is to get direct feedback from customers/users in the first place. It is all very well saying use surveys – but how many surveys have you been sent that just end up in the bin (trash)! Auditors must know this – so is this just a tick the box game they must play?:2cents:

Steve
 
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sreenu927

Quite Involved in Discussions
#12
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Steve & Chris,

Thanks for your suggestions. But still, am not clear on this PMS.
Is it necessary to have a separate SOP for PMS, if so, what shud be the content?
How to address this issue of PMS?

In NB-MED/2.12/ Rec 1 PMS document, it is mentioned that "....experience with similar devices made by the same or different manufacturer" as one of the sources for PMS. I believe, it is as same as competitor's data.

We have documents for analysis done for complaints, CAPRs, SOP for Vigilant system, exhibitions(of our product), scientific literature(for our product).

Thanks & Regards
Sreenu
 
S

SteveK

#13
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Sreenu,

Here is what I have done (hopefully to keep an auditor happy, cover my back etc). Within the hierarchy of documents – QM, SOPs, Work Instructions and so on down the line, I have created a top level SOP for Post-Marker Surveillance which basically highlights what I already have in place i.e. to make it bl**dy obvious for an auditor (like in your driving test – deliberately pointing your face at the rear view mirror to show the instructor you are checking behind you!). This SOP indicates that I have SOPs for “Handling Complaints”; “Recall & Advisory Notices”; “Internal Auditing”; “CAPA” and “Quality Management Improvement”. It also indicates all the supplementary forms (templates) and inputs (sources of feedback and analysis) that I have available/created – it references MEDDEV 2.12-1 rev 5 etc as well. It may be a little OTT – but for auditing purposes, that is the point – IT SHOWS I HAVE CONSIDERED IT, MADE AN EFFORT!

Steve
 

sreenu927

Quite Involved in Discussions
#14
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Steve,

So, is it ok, if we REFERENCE other vigilance system procedures in this SOP?
Is there any procedure else to satisfy auditor that we have considered all the NB-MED and MDD requirements?
If you don't mind, cud u plz share the template?

I am planning as follows:
1. As mentioned by Chris, prepare a spreadsheet and do literature survey of competitor products (including risk analysis,clinical evaluation of those products) indicating the frequency for the survey.
2.Considering the Vigilance SOPs in 2,3,4 (or so..) points.
3. Semi-annual Analysis of complaints/complaints review (apart from clearing complaints as and when received)
4. Consideration of Annual customer feedback survey. (No idea if there is any particular quantitative requirement for this??)
5. Exhibitions, seminars or talks or training programs to dentists (our customers) shall be conducted as and when required(proof of previous, if any).

Advise me.

Thanks,
Sreenu
 
S

SteveK

#15
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Sreenu,

Reference anything (guidance etc) that is relevant (see attached) in my view. As said before, I believe it is the surveillance of your products that is the main goal of the MDD requirement. But looking at other sources of information (as you suggest), at least shows that you are being ‘proactive’ to an auditor in your quest for feedback. I do not know if the SOP attachment (template) will be much use – as it references my other documents, forms and systems (these I cannot supply).

Hope this helps!

Steve
 

Attachments

M

Marlin

#16
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

I too had a suggestion during last year's audit of ISO13485MDD, etc. to come up with a stronger post market surveillance system.

We have used a Marketing Feedback form for a long time. I have begun to collect all the positive forms and file them in the post market surveillance file since they all eventually end up with me for storage. I have to remind the sales personnel and customer service to write up the positive comments. They never fail to give me complaints. We also ask the trade show attendees to document positive remarks for us. My next audit is in June so I will see what the auditor has to say about this system.

Marlin
 

sreenu927

Quite Involved in Discussions
#17
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Dear Steve,

Thank you for the template, yeah, it is a quite useful one, inlines of my draft, but more clear with inclusion of ISO and MDD requirements.

Hi Marlin,
Thanks for sharing the info.

Regards
Sreenu
 
R

Roland Cooke

#18
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

One of the questions I ask to test the efficacy of a company's PMS system is:

"If your competitor's similar device had problems in the field, how would you learn about those problems, then, how would you determine if those problems might also affect your devices (i.e. possibly in the very near future)?"

I then look to see if the PMS procedure matches the response.


A lot of companies tend to overlook the fact that they have an entire department part-dedicated to PMS. It's called "Marketing".
 
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