Understanding the intricate dynamics of payer preferences and decision-making criteria allows stakeholders in the healthcare landscape to align their offerings with payer requirements, fostering mutually beneficial relationships and ensuring the acceptance of innovative healthcare solutions.
Navigate the complexities of SSCP development with expert insights on ensuring compliance, readability, and alignment with EU MDR Article 32 for medical devices.
Since the implementation of the Medical Device Regulation (2017/745) (MDR) in Europe, manufacturers must proactively monitor the safety and performance of their medical devices throughout their entire lifecycle. Post-Market Clinical Follow-Up (PMCF) surveys have become widely accepted as an essential component of PMCF data collection. These surveys are a valuable tool for gathering real-world data … Continued
The MDR introduces more stringent requirements for medical device manufacturers, emphasizing patient safety and a clinical evidence-based approach to the confirmation of the benefit-risk determination for each device. Under the MDD, the term PMCF was associated with formal post-market studies and only considered necessary for a few high-risk or novel devices. Under the MDR, PMCF is an integral part of the post-market surveillance (PMS) process applicable for all devices. Another important change with the MDR is that PMCF is defined as a continuous process which updates the clinical evaluation. To place a product on the market in Europe under the MDR is therefore a commitment to continue to gather information, including clinical data, for the lifetime of the device. Further insights are available in the white paper on device lifetime co-authored by NAMSA and BSI.
MDCG 2024-10, published in June 2024, addresses the difficulties in generating clinical data for devices specifically intended for use in rare diseases/conditions or specific indications for rare cohorts of patients with non-rare diseases/conditions. The MDCG introduces the phrase orphan devices to identify those devices that have precise indications used in a small patient population where gathering sufficient pre-market clinical data can be challenging, particularly given the increased requirements of the Medical Device Regulation (MDR).