Do NOT fall into the trap that has ensnared so many others - Post-market clinical follow-up (PMCF) and post-market surveillance (PMS) are NOT the same.

Post Market Surveillance (PMS) is a requirement stipulated in ISO 13485, Section 8.2.1, and is a requisite for CE marking.

Post-market Clinical Follow-up (PMCF) is a separate requirement stipulated in Annex X, Section 1.1c of the EU Medical Device Directive (MDD).

There are a variety of MEDDEV and other guidance documents governing the organization and conduct of a comprehensive PMCF study but the most important concept is that your PMS is not your PMCF. There is a possibility that your device does not require a PMCF and if this occurs the justification must be written, ethically compelling and approved by a senior executive.

A PMCF is undertaken in a variety of circumstances:

1. At the direction of your Notified Body as a requirement for ongoing CE Mark certificates
2. At the direction of a regulatory authority
3. As an outcome of either clinical evaluation, post market surveillance or vigilance
4. To gain knowledge from first in-human uses
5. Assess feasibility and acceptance
6. Collect long term use data

Additionally, manufacturers should undertake a PMCF if any of the following circumstances apply:

a) Any assumption made during research and development; design; risk analysis; preclinical testing or clinical testing has not been substantiated in the post-production phase where its result is a potentially unacceptable risk or hazard

b) Identification of new risks that could have a critical impact on safety and/or performance.

c) The device in question is truly innovative or exceeds the state of the art

d) The medical device or its indications for use is new or presents a novel approach not widely undertaken

e) The disease or infirmity treated is quite severe (error leads to surgical intervention, extensive hospitalization, injury or even death)

f) The population the device is used on contains vulnerable segments (patients who may not be aware of an error or malfunction)

g) The anatomical location the device is used near is life sustaining or otherwise risky to the patient’s well being

h) Literature reviews, clinical evaluation, post market surveillance or other activities identify previously unknown risks or hazards

i) Vigilance reveals similar devices have encountered shortcomings that are likely to occur with your device, or

j) Information is discovered that could potentially compromise your device’s safety and/or performance.