Post Market Clinical Follow-Up Determination Form

Device Name:

Prepared by: Date: Click here to enter a date.

Circumstances that may justify PMCF Applicable? Comments/ supporting documents

studies: Yes or n/a
n/a
innovation, e.g., where the design of the
device, the materials, substances,
the principles of operation, the technology or
the medical indications are novel;
Predicates – XXX Device is manufactured by the same
manufacturer
The principle of operation and indications are the same and
the design and materials of the device are similar. There are no
novel features.

significant changes to the products or to its n/a The intended use is identical
intended use for which pre-market clinical
evaluation and re-certification has been
completed;
high product related risk e.g. based on n/a No new risks have been identified.
design, materials, components, invasiveness,
clinical procedures;
n/a Non-invasive
high risk anatomical locations;

high risk target populations e.g. pediatrics, n/a The same target population as xxx
elderly;
n/a Non-invasive monitoring xxxx
severity of disease/treatment challenges; Does not treat disease or provide treatment
n/a No clinical investigation was conducted for the device. The
questions of ability to generalise clinical
feedback and results expected from the PMS are not likely to
investigation results;
raise any questions.
unanswered questions of long-term safety n/a There are no unanswered questions of long-term safety and
and performance; performance.
results from any previous clinical n/a No adverse events reported
investigation, including adverse events or
from post-market surveillance activities;
identification of previously unstudied n/a No new subpopulations identified
subpopulations which may show different
benefit/risk-ratio e.g. hip implants in
different ethnic populations;
continued validation in cases of discrepancy n/a The device is reusable and has an expected lifetime of
between reasonable premarket follow-up
time scales and the expected life of the
product;
n/a There were no risks identified from literature and similar
risks identified from the literature or other
marketed devices
data sources for similar marketed devices;
n/a T No new risks related to interaction with other devices have
interaction with other medical products or
been identified.
treatments;
n/a The intended user is a clinician with training in xxx
verification of safety and performance of
No different population of clinical users is envisioned to use
device when exposed to a larger and more
the xxx
varied population of clinical users;
n/a No change to the safety or performance according to the PMS.
emergence of new information on safety or
performance;
n/a CER and V&V
where CE marking was based on equivalence.