PMCF Customer Report Form

For customers,
please fill in the following form to provide Omnidermal Biomedics srl with relevant information regarding Post-Market Clinical Follow-up.

Please send a copy of the report to: pms@omnidermal.it

The following Form has the purpose of increasing the clinical safety and efficacy of the WoundViewer device. This form represents a fundamental point for the manufacturer to establish and develop an effective Post-market Surveillance Plan.

The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical followup (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing a plan, necessary to implement PMCF.

A PMCF plan shall specify the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from the use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred to in the relevant conformity assessment procedure.

The aim of the PMCF plan is:

– confirming the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime;

– identifying previously unknown side-effects and monitor the identified side-effects and contraindications;

– identifying and analysing emergent risks on the basis of factual evidence;

– ensuring the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR;

– identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.