SCimPULSE Foundation heeft dit gerepost
This is shocking. An authority in the Netherlands (IGJ) audited 13 medical device manufacturers and found that NONE had adequate post market surveillance in place, despite there being strict requirements in the regulations. The inspections focused primarily on micro, small, and medium-sized enterprises, covering Class I medical devices, software applications, and in-vitro diagnostics (IVDs) that are being marketed as legacy devices. A little more than half of the manufacturers had a PMS plan. In some cases, so much information was missing from the PMS plan that the IGJ considered it to be non-existent. Many manufacturers did not tailor their PMS plan to the type of medical device they were marketing (i.e. they had copy/pasted a generic PMS template and left it at that) None of the visited manufacturers fully complied with the PMS requirements of the MDR or IVDR. As a result, enforcement measures have been or will be imposed on these manufacturers. In essence, the manufacturers were not giving PMS the appropriate attention and priority, and risked patient safety, as well as their ability to stay on market. Come on people, we can, and should, do better. https://lnkd.in/etFi_rS2