The regulatory expectations are increasing which is apparent due to the increased market surveillance activities by the authorities. They are less tolerant of failure of the product on the market and the proof of compliance for the manufacturer becomes imperative throughout the lifetime of the products.
The new proposed Medical Devices Regulation (MDR) in Europe is a significant increase of requirements in all areas. Post-market surveillance (PMS) has become a core element of the MDR.
With its own paragraph within the foreword the stage is being set. The importance bestowed upon the PMS is shown by the Articles and its own Annex in the MDR proposal. Furthermore the post-market surveillance is incorporated throughout the MDR with various other requirements.
Only with a solid post-market surveillance system will the manufacturer be able to provide the objective evidence of compliance.
The presentation addresses the PMS requirements and frameworks the relation with other aspects of the regulation.
Ludger Möller,, Vice-Chairman, EAAR; President, Medical Device Safety Service GMbH, Germany