REQUIRED CLINICAL PMS ON MARKET MONITORING
Continuous post-marketing clinical monitoring
Following the launch of the medical device, the new MDR (Annex XIV Part B) requires a post-market clinical follow-up to continuously assess benefits and risks. Above all, it is about possible long-term risks that were not detected during the pre-market clinical evaluation.
The results of the follow-up should be taken into account in the continuous update of the clinical evaluation and risk management. Clinical evaluation is therefore an ongoing process that must be repeatedly documented through regularly reviewed plans and reports by the Notified Body
To do this, manufacturers need to gather clinical data to continuously assess potential safety risks. The manufacturer shall establish a structured system of long-term follow-up (cPMS) including clinical trial results, registers, controls or random checks.
The documentation includes significant updates from the MDR, including additional reports and plans such as Post Market Surveillance Plan / Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP).
For defined product groups, manufacturers must submit the safety / clinical evaluation / performance summary reports on the safety and performance of their products annually. In particular, this applies to Class III medical devices and implantable devices that are subject to more stringent clinical requirements for clinical PMS in 2017 EU MDR.
Certain incidents during PMS (and also during clinical trials) are notifiable. Reporting takes place via the electronic system for vigilance and post-marketing surveillance (currently DIMDI) to the Federal Institute for Drugs and Medical Devices (BfArM) or to the Paul Ehrlich Institute (PEI).
Clinical Evaluation & Writing.
The Clinical Assessment Body, Prof. Zenner and Partners, can assist with the establishment and implementation of the Post-Market Clinical Follow-Up and Post Market Surveillance Plan / Report (PMS), Post Market Clinical Follow-up Report (PMS). PMCF), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and Clinical Evaluation / Performance Summary Reports.