Medical Devices
Post Market Clinical Follow up Form
DIRECTIVE
NSAI File No. (NSAI Use ONLY)
MDD (93/42/EEC)
252.
/
AIMD (90/385/EEC)
253.
/
This NSAI post market clinical follow-up form is drafted as per the
recommendations of the guidance document MEDDEV 2.12/2 Rev 2 (Jan 2012) –
Guidelines on post market clinical follow-up studies.
Section A to be completed by manufacturer prior to market approval
Please Tick
Justification for no PMCF
protocol
PMCF protocol
Go to Section A 1 and complete
Go to Section A 2 onwards and
complete
Section B to be completed by the manufacturer post CE mark approval
Product Approval date (dd/mm/yy)
Please Tick
Product on market
Yes
No
Date gone on market (dd/mm/yy)
Please note:
When submitting this form and supporting data please do so via our upload
facility at http://www.nsaiinc.com/upload/CEMARKING/.
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Section A
PMCF protocol or justification for none:
A1. Please provide a justification if no post market clinical follow-up (PMCF) e.g. study or
registry is planned as part of the post market surveillance for the device. Please
include reference to assessment of residual risks and long term performance of the
device in the justification. In particular please assess the acceptability of not doing
PMCF if the clinical evaluation was based exclusively on clinical data from deemed
equivalent devices for initial conformity assessment
Response:
NSAI Review:
Disposition:
A2. If PMCF is planned please submit the post market clinical follow-up plan (with
identifier) for NSAI review and approval. The PMCF plan should be approved, signed
and dated by the manufacturer and the manufacturer’s clinical expert.
Please list all the elements of the planned PMCF as following with study identifiers etc.
 Clinical study/studies of CE marking devices
 Clinical registry / registries of CE marking devices
 Clinical investigation(s) (e.g. outside intended use or in another jurisdiction
relevant to the device)
 Clinical literature review
 Others
Response:
NSAI Review:
NSAI reviewer to review appropriateness of the address the manufacturer’s stated objectives and the
ability of the plan to assess the residual risks and long term safety and performance of the device
Disposition:
A3. Please submit the CV of the clinical expert who approved the PMCF plan
Response:
NSAI Review:
Disposition:
A4. Please submit a declaration of impartiality for the clinical expert
Response:
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NSAI Review:
Disposition:
Section B
Post Market Clinical follow up data review
Note:
In situations where the device has not been commercialised, the CER should be
updated with the results of any clinical investigations or literature or other
relevant clinical data for the device or similar devices, and the CER should be
submitted to NSAI prior to commercialisation to support the continued safety and
performance of the device.
Following approval of the device NSAI seeks the following information
1. PMCF protocol – please advise of any change to the protocol as presented in section A
above
Response:
NSAI Review:
Disposition:
2. PMCF reporting timelines / dates to comply with approval
Response:
NSAI Review:
Disposition:
3. Updated Clinical Evaluation Report with data from the post market clinical follow up
as agreed with NSAI and at the timelines agreed. The CER should be updated with all
relevant clinical information regarding the safety and performance of the device and
the conclusions updated with regard in the continuing positive clinical risk benefit
analysis of the device and compliance with the Essential Requirements. If the device
has received any unfavourable regulatory reviews since approval please include an
analysis. The report should be signed and dated by the manufacture and the clinical
expert evaluator.
Response:
NSAI Review:
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Disposition:
4. Curriculum of clinical evaluator (if not already submitted)
Response:
NSAI Review:
Disposition:
5. Declaration of impartiality of Clinical evaluator (if not already submitted)
Response:
NSAI Review:
Disposition:
NSAI PMFC Review No.1
Date:
Reviewer:
NSAI Queries
Company Query #1 –
Company Response
Response Disposition:
Company Query #2 –
Company Response
Response Disposition:
Company Query #3 –
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Company Response
Response Disposition:
Company Query #4 –
Company Response
Response Disposition:
Query Disposition Summary:
Query
1.
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Disposition
Date
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