Post Market Surveillance Report (PMSR) for Medical Devices

S

StepPCHen

Starting to get Involved
#1
#1
Good afternoon everyone,

I have a quick question on PMSR for Class Is Devices. I am completing a Template for PMSR to be used in conjunction with the Post Market Surveillance Plan (PMSP).

The question surrounds information related to other devices - Adverse events. The FDA has the MAUDE Database, but as we are based in the EU and distribute to the EU I was looking for an EU equivalent to the FDA's MAUDE database. I know EUDAMED will serve this purpose, but as of today, this function is not yet available.

If there is no equivalent, I would be interested in learning what other EU-based manufacturers are doing to satisfy the requirements, or can we use MAUDE? Or is it a case of contacting each Competent Authority?

Thank you
 
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S

Sinus Tarsi

Starting to get Involved
#2
#2
We are in the US and distribute to the EU. Until EUDAMED is up and running we have to check with each countries MOH quarterly! Please share if you figure out another way.
 
S

StepPCHen

Starting to get Involved
#3
#3
Sinus Tarsi said:
We are in the US and distribute to the EU. Until EUDAMED is up and running we have to check with each countries MOH quarterly! Please share if you figure out another way.
Click to expand...
Just out of curiosity, did you include contact details for each MHO in your procedure? I will be sure to update this thread if I find any other techniques.
 
Raisin picker

Raisin picker

Quite Involved in Discussions
#5
#5
I'm not sure you're required to use only EU CAs. The big problem is that most CAs don't offer public access to their security databases. Two better databases to query are MHRA (UK) and Swissmedic, both not in the EU (anymore). Afaik, TGA (Australia) also offers a searchable database.
I think you should cover (more or less) the regions you sell to and important markets for your device type. Currently, you could exclude most CAs from the list above for not being searchable.
 
S

Sinus Tarsi

Starting to get Involved
#6
#6
Raisin picker said:
I'm not sure you're required to use only EU CAs. The big problem is that most CAs don't offer public access to their security databases. Two better databases to query are MHRA (UK) and Swissmedic, both not in the EU (anymore). Afaik, TGA (Australia) also offers a searchable database.
I think you should cover (more or less) the regions you sell to and important markets for your device type. Currently, you could exclude most CAs from the list above for not being searchable.
Click to expand...
No, you should not 'only' use EU competent authorities. We originally did have MAUDE, MHRA, DAEN, BfArM, SwissMedic and Health Canada and were cited for not including all of the EU country authorities that we market to - even though you cannot access most without registering an account. We explained this should be the responsibility of the distributor located in each country but they did not like that.
 
C

Cybel

Involved In Discussions
#7
#7
While waiting EUDAMED is working, here you can find links to device safety information as published by IMDRF National Competent Authority Report (NCAR) Exchange Members: Safety information

Some links are duplicated or not properly working; however I’ve find them helpful and I've included in my procedure a reference to this website.
In my periodic records I detail all the information I've found for each country/link.
 
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