EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)"

[kimp1546]

MY notified body wants me to add to my PMS SOP the definition of "register(s)". I added it to state that the term "register(s) is a database of information that is searchable to gain knowledge or information."

They have responded to me stating that that is the incorrect definition of the term. Can someone please tell what the definition of register(s) is when applied to PMS and PMCF (Post-Maintenance Check Flight).

Thank you in advance for your help!

 

[FoGia]

Hello,

There's a MEDDEV providing the definition you're looking for (device registry): MEDDEV 2.12/2 rev.2
I would advise you to look at the meaning of PMCF as well.

 

[SK13485]

FYI, you have the wrong terms mentioned here...it is REGISTRY and the PMCF stands for Post Market Clinical Follow-up.

Device registry as defined by MEDDEV 2.12/2 states : "An organised system that uses observational study methods to collect defined clinical data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s).