Definition MDR, MDVR, MPR - Definitions - ISO 13485 - Medical Devices

RCW

Quite Involved in Discussions
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:
 

Jim Wynne

Leader
Admin
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

Could somebody please enlighten me?

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

RCW

Quite Involved in Discussions
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.
 

chris1price

Trusted Information Resource
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!
 

RCW

Quite Involved in Discussions
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?
 
C

CBAL08

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