PMCF Plans and Reports 

Post Market Clinical Follow-up as an update to the clinical evaluation

The Medical Device Regulation (EU) 2017/745 (MDR) has re-enforced post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation.

Here at Aolete, we support our clients to conduct a comprehensive evaluation of activities to be implemented during the Post Market Clinical Follow up period based on the conformity assessment set forth by the Clinical Evaluation Report.

Our team of experts is committed to developing PMCF plans and reports which: 

• Confirm the safety and performance that address the clinical benefits of the device throughout its expected lifetime

• Identify known side effects as well as monitor and analyze identified side effects and contraindications

• Based on factual evidence to analyze and report emergent risks

• With documented evidence, ensure continued acceptability of the Benefit/Risk ratio