During the course of peforming a self-audit to ISO 13485 (don't ask) I ran across the following acronyms - MDR, MDVR, MPR. This was in the customer complaints section, I do believe.

From what I could find MDR = Medical Device Reporting?

I'm assuming these items have to do with reporting to an agency upon an injury due to the failure of a medical device?

Could somebody please enlighten me?

:thanks:

During the course of peforming a self-audit to ISO 13485 (don't ask) I ran across the following acronyms - MDR, MDVR, MPR. This was in the customer complaints section, I do believe.
The customer complaints section of what?

From what I could find MDR = Medical Device Reporting?

I'm assuming these items have to do with reporting to an agency upon an injury due to the failure of a medical device?

Here's the FDA webpage on MDR (http://www.fda.gov/cdrh/mdr/)

Could somebody please enlighten me?

That's about as far as I can go; I don't know what MDVR and MPR refer to.

The customer complaints section of what?

Whoops, sorry if I left out the specifics. I am looking at ISO 13485, section 8.5.1 General.

This self-audit form I'm dealing with covers U.S. (where MDR shows up), Canada and Europe. Maybe the MDVR and MPR are reporting systems for the latter two.

During the course of peforming a self-audit to ISO 13485 (don't ask) I ran across the following acronyms - MDR, MDVR, MPR. This was in the customer complaints section, I do believe.

From what I could find MDR = Medical Device Reporting?

I'm assuming these items have to do with reporting to an agency upon an injury due to the failure of a medical device?

Could somebody please enlighten me?

:thanks:

MDR - Medical Device Report; for FDA in USA
MDVR - Medical Device Vigilance Report; for EU. See Meddev 2.12/1
MPR - No Idea!

MDR - Medical Device Report; for FDA in USA
MDVR - Medical Device Vigilance Report; for EU. See Meddev 2.12/1


Thanks for bringing us one step closer, Chris, and welcome to the Cove. :agree1:
MPR - No Idea!
Wouldn't that be "NI"? :lol:

It looks like the US and EU are covered. Would that leave the MPR as being a Canadian requirement? Any Canadian medical device Cove members out there?

During the course of peforming a self-audit to ISO 13485 (don't ask) I ran across the following acronyms - MDR, MDVR, MPR.
Could somebody please enlighten me?

:thanks:

Hi RCW,

MDR—Medical Device Reporting (USA)
MDVR—Medical Device Vigilance Report (EU)
MPR—Medical Problem Report (Canada)

Hi RCW,

This is the website of Health Canada. Use the "search" to get any info on MPR. Btw, this site is also very informative as fda website.

http://www.hc-sc.gc.ca/index_e.html

:applause: Thank you all!

Looking for example of Procedure/Flowchart or a table which has all the three included MDR (US), MDVR (EU) and MPR (Canada)

Can anyone help me to find a way to write all the three combined...any example...I am getting too confused with all these...Please help.

Can anyone help me to find a way to write all the three combined...any example...I am getting too confused with all these...Please help.

Can any of our Medical Devices folks help out here?

Thanks!

Stijloor.