Merging Post Market Surveillance and Complaint Handling

[scotthowells]

Hi All,
Recently joined a small medical device start up with about 4 years of history, not yet on the market however. Aiming to enter EU market followed by US. During an notified body audit 2 years ago the auditor recommend the merging of the Post Market Surveillance and complaints handling SOPs. This was subsequently done.

This is different to how I have seen PMS and complaints set up before and I am thinking of pulling them apart again so they are distinct procedures. One for PMS and one for complaint handling.

Can I ask for some thoughts on this given our desire to be both in EU and US?
Thanks,
S

 

[shimonv]

Re: Post Market Surveillance and Complaint Handling

Hi Scott,
It's very unusual to merge Complaint and Post-Market surveillance procedures.
But this was two years ago and you had not much to show back then.

I recommend that you separate the procedure. As you know, PMS is an EU requirements; it is not relevant for the US market. It would be sufficient for you to work on one Complaint SOP that addressed both EU and US requirements.


Cheers,
Shimon

 

[somashekar]

Re: Post Market Surveillance and Complaint Handling

PMS is a proactive activity.
Complaints is reactive upon receipt of one.
PMS has various methods of approach .. MDR being the FDA process for this. See THIS
The EU PMS and the PMCF have different guiedlines (MEDDEV 2.12/2)

Complaints are to be handled differently as and when you get the complaints. The FDA 21 CFR 820.198 tells more in detail, and leads you to FDA part 803. There are timelines for response.

You need to have different procedures to better address these requirements, as they may be handled by different sections of people...

 

[scotthowells]

Thanks for confirming my direction and thinking, I found it really strange this was a recommendation from an NB auditor.
Regards,
Scott