Summary of Safety and Clinical Performance Best Practices

Navigate the complexities of SSCP development with expert insights on ensuring compliance, readability, and alignment with EU MDR Article 32 for medical devices.

When, Why, and How to Use Post-Market Clinical Follow-Up (PMCF) Surveys

Real-World PMCF Under the MDR: Cost Effective PMCF Strategies and Plans

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 Clinical Evaluation of Orphan Medical Devices

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).

FDA Releases "Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles"

On June 13, 2024, the FDA, Health Canada, and the MHRA jointly published the “Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles | FDA.” This new publication has further identified guiding principles for transparency for machine-leaning -enabled medical devices (MLMDs)