Post Market Clinical Follow up (PMCF) is a clinical data. MDR Clinical data definition has many sources of clinical data including PMCF.
Annex XIV-Part B PMCF Requirements,
-Continuous process that updates the clinical
evaluation
-Shall be addressed in the manufacturer's post-market
surveillance plan.
-PMCF is a proactive PMS (Post market surveillance).
Manufacturer shall collect the clinical data proactively from CE marked devices
Aim of the PMCF (Annex XIV-Part B section 6.1)
|
(a) confirming the
safety and performance of the device throughout its expected lifetime |
|
(b) identifying
previously unknown side-effects and monitoring the identified side-effects
and contraindications, |
|
(c) identifying and
analysing emergent risks on the basis of factual evidence, |
|
(d) ensuring the
continued acceptability of the benefit-risk ratio referred to in Sections 1
and 9 of Annex I, and |
|
(e) identifying
possible systematic misuse or off-label use of the device, with a view to
verifying that the intended purpose is correct. |
PMCF Plan (Annex XIV-Part B section 6.2)
-General methods and procedures of the PMCF 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 PMCF to be applied
& Rationale for chosen method
o
Evaluation
of suitable registers
o
PMCF
studies
-A reference to the relevant parts of the clinical
evaluation report and to the risk management
-Any specific objectives to be addressed by the PMCF
-An evaluation of the clinical data relating to
equivalent or similar devices
-Reference to any relevant CS, harmonised standards
-Justified timelines for PMCF activities
PMCF Plan Template Format (MDCG 2020-7)
1.Section A. Manufacturer contact details
2.Section B. Medical Device description and specification
3.Section C. Activities related to PMCF: general and specific
methods and procedures
4.Section D. Reference to the relevant parts of the technical
documentation
5.Section E. Evaluation of clinical data relating to equivalent or
similar devices
6.Section F.Reference to any applicable common specification(s),
harmonized standard(s) or applicable guidance document(s)
7.Section G. Estimated date of the PMCF evaluation report
PMCF Report Template Format
(MDCG 2020-8)
1.Section A. Manufacturer contact details
2.Section B. Medical Device description and specification
3.Section C. Activities undertaken related to PMCF: results
4.Section D. Evaluation of clinical data relating to equivalent or
similar devices
5.Section E. Impact of the results on the technical documentation
6.Section F.Reference to any common specification(s), harmonized
standard(s) or guidance document(s) applied
7.Section G. Conclusions
Post-market surveillance plan shall cover a PMCF plan
or a justification as to why a PMCF is not applicable. (Annex III 1.1(b)).
Clinical evaluation plan has clinical development plan
(CDP). CDP shall cover PMCF.
PMCF evaluation report shall be part of the clinical
evaluation report and the technical documentation.
All device classes shall have a PMCF which is used to
update a Clinical evaluation. PMCF activity is exempted when there is a
sufficient clinical evidence to prove the safety and performance throughout the
expected lifetime of the device. Justification for not conducting a PMCF
activity can be given within the Technical documentation. CER will assess the
sufficient clinical evidence and identified gaps are addressed through PMCF.
MDD CE marked legacy devices based on equivalence
clinical evidence need PMCF studies to comply MDR.
MEDDEV 2.12/2 (Post Market Clinical Follow-up Studies
Guide) have circumstances that may require PMCF studies.
Frequency of PMCF
updates
|
Class |
Timelines |
|
Class
III/Implantable devices (Class II b/II a) |
Annually
(Article 61(11) |
|
Class II b Non Implants |
Annually (based on
PSUR timelines) |
|
Class II a Non Implants |
Every 2 years (based
on PSUR timelines) |
|
Class I |
When required (based
on PMS timelines) |
References
1.REGULATION (EU)
2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC
2.MEDDEV 2.12/2 rev2 -
POST MARKET CLINICAL FOLLOW-UP STUDIES A GUIDE FOR MANUFACTURERS AND NOTIFIED
BODIES
3.MDCG 2020-6 Guidance
on sufficient clinical evidence for legacy devices
4.MDCG 2020-7 Guidance
on PMCF plan template
5.MDCG 2020-8 Guidance
on PMCF evaluation report template
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