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

Z

zkoulou

#21
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Al.
what template? it has been awhile
 
Elsmar Forum Sponsor
T

tec11

#22
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Thank you sooo much. this doc was immensely useful to me.
 

RCW

Quite Involved in Discussions
#23
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

As a contract manaufacturer of medical devices, would I need to have a PMS system in place? (Assume ISO 13485 requirements are present.) As hard as it is to get feedback out of the user of the medical device, when you are a level below the company marketing the device, it's even more difficult.

Note: My customers are addressing the advisory notices and are interfacing with the medical device users.
 
M

MIREGMGR

#24
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

As a contract manaufacturer of medical devices, would I need to have a PMS system in place? (Assume ISO 13485 requirements are present.)
No as a regulatory requirement.

Maybe yes as a contractural requirement, if one or more of your customer agreements calls for it.
 
S

SteveK

#25
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

I suppose if there was a problem with a competitors product it would be relevant, but this would be captured in a Device Alert (a MDA, Safety Notice or Recall in the UK - available on the MHRA site) of some form (i.e. a publication again).
Just as a follow up to my comment about using alerts, FSNs, recalls, safety notices etc (e.g. issued in the UK by MHRA) as a form of PMS i.e. monitoring for medical devices similar to your own, these sites listed may be useful. Obviously it can be a pain to trawl through a lot information to find anything relevant, but at least I can show an auditor a degree of vigilance. I do this by recording the total number of alerts etc for each month and authority on a spreadsheet. Then I highlight any link to the type of devices similar to our own. You may encounter a problem you were not aware of, so then you can update your Risk Assessment file accordingly. For foreign language sites you can use the Google translator. Note for the FDA site since so many alerts are thrown up, I filter these by worst case i.e. causing ‘death’ (it helps first off to get the 3 letter code for your type of device for the search).

MHRA
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/index.htm

FDA
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM

HC (Canada)
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/index-eng.php

MDB (Malaysia)
http://www.mdb.gov.my/mdb/index.php?option=com_content&task=view&id=69&Itemid=119

HAS (Hong Kong)
http://www.mdco.gov.hk/english/recalls/recalls.html

IMB (Ireland)
http://www.imb.ie/EN/Medical-Devices/Safety-Notices.aspx

Saudi FDA
http://212.100.220.58/services/md_Recalls/recallsDispaly.aspx

Afssaps (France)
http://www.afssaps.fr/Infos-de-securite/Autres-mesures-de-securite#dm

bfarm (Germany)
http://www.bfarm.de/cln_103/EN/medDev/riskinfo/fca/fca-node.html

Salute (Italy)
http://www.salute.gov.it/dispositivi/archivioAvvisiDispo.jsp?menu=avvisi&lingua=italiano

Swissmedic
http://www.swissmedic.ch/rueckrufe_medizinprodukte/archiv/index.html?lang=de&RlArchiv=2010-07
Not all countries publish details of their alert, but if anyone else knows of any other sites that do, please let me know.

Steve
 
M

MegSinha

#26
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Hi Steve,

My Company has the PMCF NC from our NB, I am currently working on putting a procedure together but the post related to Post Market Clinical follow up named
"Post Market Surveillance Guidelines or examples of procedures"
(I just joined so can't put the exact link )
In this post Sam says that it is not deemed necessary if duly justified? Do you think its just better do it or it is better to justify why we are not doing it since the product classification is IIa?

Please advise.
 
S

SteveK

#27
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

The link is:

Post Market Surveillance Guidelines or examples of procedures

Anyway I believe a "clinical follow-up" relates to implantable/class III products. There is a current case (originally initiated by the FDA) that DePuy (J&J) must conduct a "clinical follow-up" on their metal on metal hip replacements (i.e. on individual patients) - which have now been withdrawn. I think this is the context of the requirement, so I do not see how it could easily relate to a class IIa device. As Sam says, PMCFU is a sub-set of PMS. I would be interested in what your NC actually says. It may be down to how your NB defines PMCFU i.e. for your class IIa device instead that is the problem.

Steve
 
M

MegSinha

#28
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

This is what exactly the NC says:
... "The procedure on Post-Market Surveillance System was provided. Although it refers to the need to establish “a post market surveillance plan for each product”, it does not introduces the notion of Post Marketing Clinical Follow-up as required by the Medical Device Directive in it Annex X - section 1.1.quater"

... What I figured is that they needed a PMCFU to be a part of our PMS, but as I said in Annex X though is does not state explicitly, it does state that this is required for Class III and implantables, so should I just add a procedure for clinical evaluation or should I talk to them and say that our product is Class IIa, does not require clinical evaluation?
 
S

SteveK

#29
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

This is what exactly the NC says:
... "The procedure on Post-Market Surveillance System was provided. Although it refers to the need to establish “a post market surveillance plan for each product”, it does not introduces the notion of Post Marketing Clinical Follow-up as required by the Medical Device Directive in it Annex X - section 1.1.quater"

... What I figured is that they needed a PMCFU to be a part of our PMS, but as I said in Annex X though is does not state explicitly, it does state that this is required for Class III and implantables, so should I just add a procedure for clinical evaluation or should I talk to them and say that our product is Class IIa, does not require clinical evaluation?
You will require a clinical evaluation, but this can be done by the literature route (I have have an example document if you do a search on 'humidifier'). I do not think this is the same as a PMCFU for a Class IIa device for the reasons already stated.

Steve
 
M

MegSinha

#30
Re: Post-Market Surveillance required by the EU’s MDD vs. ISO 13485 requirements

Thanks a lot Steve. That helps!
 
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