Post Market Clinical Follow-Up Determination Form

Device Name:

Circumstances that may justify PMCF studies:

Applicable?

Yes or n/a

Comments/ supporting documents

innovation, e.g., where the design of the device, the materials, substances,

the principles of operation, the technology or the medical indications are novel;

n/a

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 intended use for which pre-market clinical evaluation and re-certification has been completed;

n/a

The intended use is identical

high product related risk e.g. based on design, materials, components, invasiveness, clinical procedures;

n/a

No new risks have been identified.

high risk anatomical locations;

n/a

Non-invasive

high risk target populations e.g. pediatrics, elderly;

n/a

The same target population as xxx

severity of disease/treatment challenges;

n/a

Non-invasive monitoring xxxx

Does not treat disease or provide treatment

questions of ability to generalise clinical investigation results;

n/a

No clinical investigation was conducted for the device. The feedback and results expected from the PMS are not likely to raise any questions.

unanswered questions of long-term safety and performance;

n/a

There are no unanswered questions of long-term safety and performance.

results from any previous clinical investigation, including adverse events or from post-market surveillance activities;

n/a

No adverse events reported

identification of previously unstudied subpopulations which may show different benefit/risk-ratio e.g. hip implants in different ethnic populations;

n/a

No new subpopulations identified

continued validation in cases of discrepancy between reasonable premarket follow-up time scales and the expected life of the product;

n/a

The device is reusable and has an expected lifetime of

risks identified from the literature or other data sources for similar marketed devices;

n/a

There were no risks identified from literature and similar marketed devices

interaction with other medical products or treatments;

n/a

T No new risks related to interaction with other devices have been identified.

verification of safety and performance of device when exposed to a larger and more varied population of clinical users;

n/a

The intended user is a clinician with training in xxx

No different population of clinical users is envisioned to use the xxx

emergence of new information on safety or performance;

n/a

No change to the safety or performance according to the PMS.

where CE marking was based on equivalence.

n/a

CER and V&V