Management Representative and PRRC (Person Responsible for Regulatory Compliance)

J

James

Involved In Discussions
#1
#1
Hi

Just wanted to check - I'm assuming that there is no reason why the PRRC couldn't be the same person as the Management Representative?

Thanks

James
 
renenatasha

renenatasha

Involved In Discussions
#6
#6
James said:
Hi

Just wanted to check - I'm assuming that there is no reason why the PRRC couldn't be the same person as the Management Representative?

Thanks

James
Click to expand...
Read thru the requirements for PRRC. If the requirements are fulfilled, there's no reason why the MR can't be the PRRC. Just remember to document the appointment either through JD (Job Description) or Appointment Letter depending on the your company system.
 
M

MDRResearcher

Registered
#7
#7
Regarding requirements for PRRC as per article 15:
does ISO 9001 count as QMS related to medical devices in relation to
"at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; "?
 
J

James

Involved In Discussions
#8
#8
MDRResearcher said:
Regarding requirements for PRRC as per article 15:
does ISO 9001 count as QMS related to medical devices in relation to
"at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; "?
Click to expand...
If your medical devices are controlled within your 9001 system, being responsible for running it for a year would seem appropriate experience to me. However, we have chosen to focus on specialist knowledge of what we are making as being the most important characteristic for the PRRC; so it's not me (as quality lead), but a clinical scientist who is better able to interpret specialist information relating to devices.
 
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