4. Elaborate clinical post market surveillance

Post Market Surveillance (PMS)

According to EU-MDR Annex XIV Part B, Post Market Surveillance (PMS) is an ongoing process of updating the clinical evaluation with z.T. shorter reporting deadlines and immediate reporting of reportable incidents. This applies in particular to Class III medical devices and to implantable devices that are subject to more stringent clinical requirements for PMS in 2017 EU MDR. Belonging to the clinical PMS are:

  • Post Market Surveillance Plan / Report

  • Post Market Clinical Follow-up (PMCF)

  • Other studies

  • Vigilance system / notification of incidents (BfArM / PEI)

  • Customer contacts

  • Literary observation

  • Assessment and measures for any off-label uses

  • Continuous review and update of Clinical Assessment