Post Market Performance Follow up (PMPF)
Annex XIII-Part B PMPF Requirements,
-Continuous process that updates the performance
evaluation
-Shall be addressed in the manufacturer's post-market
surveillance plan.
-PMPF is a proactive PMS (Post market surveillance).
Manufacturer shall collect the performance and relevant scientific data proactively
from CE marked devices
Aim of the PMPF (Annex XIII-Part B section 5.1)
|
(a) confirming the
safety and performance of the device throughout its expected lifetime |
|
(b) identifying previously unknown risks
or limits to performance and contraindications, |
|
(c) identifying and
analysing emergent risks on the basis of factual evidence, |
|
(d) ensuring the
continued acceptability of the clinical evidence and of the benefit-risk
ratio referred to in Sections 1 and 8 of Chapter I of Annex I, |
|
(e) identifying
possible systematic misuse |
PMPF Plan (Annex XIII Part B section 5.2)
-General methods and procedures of the PMPF to be
applied & Rationale for chosen method
o
Gathering
of clinical experience gained,
o
Feedback
from users
o
Screening
of scientific literature and of other sources of clinical data
-Specific methods and procedures of PMPF to be applied
& Rationale for chosen method
o
ring
trials and other quality assurance activities
o
epidemiological
studies
o
evaluation
of suitable patient or disease registers
o
genetic
databanks
o
post-market
clinical performance studies
-A reference to the relevant parts of the performance
evaluation report and to the risk management
-Any specific objectives to be addressed by the PMPF
-An
evaluation of the performance data relating to equivalent or similar devices and the current state of the art;
-Reference to any relevant CS, harmonised standards and relevant guidance on PMPF
-Justified timelines for PMPF activities
The manufacturer shall analyse the findings of the
PMPF and document the results in a PMPF evaluation report that shall update the
performance evaluation report and be part of the technical documentation
Post-market surveillance plan shall cover a PMPF plan
or a justification as to why a PMPF is not applicable. (Annex III 1.1(b)) .This
justification shall be documented with performance evaluation report.
PMPF evaluation report shall be taken
into account for the performance evaluation and in the risk management referred to in
Section 3 of Annex I .
|
Class |
Timelines |
|
Class C & D |
Annually (based on PMS
timelines) |
|
Class A & B |
When required (based
on PMS timelines) |
Click below link to know more about MDR PMCF requirements:https://meddev-info.blogspot.com/2021/01/mdr-post-market-clinical-follow-up-pmcf_14.html
References
Source: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL of 5 April 2017 on in vitro diagnostic medical
devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
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