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

#1
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!
 
Last edited:
Elsmar Forum Sponsor

FoGia

Involved In Discussions
#2
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

MedDev QA/RA
#3
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).
 
Thread starter Similar threads Forum Replies Date
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
M EU MDR - Retrospective Study for expanding indications of a legacy device EU Medical Device Regulations 0
B MDR Technical Structure EU Medical Device Regulations 3
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
L Configurable UDI mdr EU Medical Device Regulations 0
O EU MDR labels EU Medical Device Regulations 1
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
C UDI for consumable/replacement components under the MDR EU Medical Device Regulations 2
E Article 17 MDR - (Re-)Processing EU Medical Device Regulations 0
H Article 22 MDR System EU Medical Device Regulations 16
L REACH compliance with MDR EU Medical Device Regulations 4
L EU MDR Ramifications for no expiration date on labeling EU Medical Device Regulations 1
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
F MDR – Article 120 – Transitional provisions EU Medical Device Regulations 8
H MDR Article 13(c) EU Medical Device Regulations 6
Ed Panek Auditor MDR (Presub audit) finding EU Medical Device Regulations 2
M Classification of Instruments under EU MDR EU Medical Device Regulations 1
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 10
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 1
S Determining a device category according to the MDR EU Medical Device Regulations 3
A Transactions under MDR Medical Device and FDA Regulations and Standards News 3
H Has anyone undergone MDR FQA review yet? EU Medical Device Regulations 10
S UK MDR + EU MDR Declaration of Conformity UK Medical Device Regulations 1
D Does Risk Management apply to re-labeler (MDR) EU Medical Device Regulations 1
H MDD VS MDR 2002-218 UK Medical Device Regulations 6
Ed Panek MDR Liability Insurance EU Medical Device Regulations 1
S MDD to MDR - Tallow Derivatives Impact EU Medical Device Regulations 1
P Update on NBOG 2014-3 to address MDR/IVDR, or any plan to do that? EU Medical Device Regulations 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
S MDR GSPR Standards EU Medical Device Regulations 1
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
F Labelling to comply with both FDA and MDR US Food and Drug Administration (FDA) 6
N EU MDR and its impact on existing Registrations EU Medical Device Regulations 1
M Post Market Safety Update Report for devices that will be up-classified under MDR but are currently under MDD EU Medical Device Regulations 6
Y MDR Transition - make "Available on the market" after CE certificate expiration EU Medical Device Regulations 3
C MDR Classification Rule 10 EU Medical Device Regulations 14
C MDR software classification EU Medical Device Regulations 12
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
R Products not within the MDR grace period EU Medical Device Regulations 1
shimonv MDR transition checklist EU Medical Device Regulations 0

Similar threads

Top Bottom