Whether your device is new or a legacy product under the IVD Directive, IVD-R post-market surveillance requirements have already gone into force. Read more about Qarad’s Post Market Surveillance services below.
Regardless of whether your device is CE-marked under the IVD-R or if it’s still in transition under the IVD Directive, IVD-R post-market surveillance (PMS) requirements are applicable as of 26 May 2022. When lodging an IVD-R application for conformity assessment of a legacy product under the IVD Directive, your notified body will expect that a PMS Report is included in the technical documentation.
PMS is different (read: more extensive) under the IVD-R than it was under the Directive. Next to reactive gathering of information, IVD-R also requires pro-active processes that include (but not limited to) systematic scanning of the scientific literature and medical device registries for performance information on your device and similar devices.
Qarad can assist you in collecting and compiling the required PMS data. Part of PMS activities will always remain with the manufacturer, but our tailored and focused services dovetail your specific needs processes. Contact us to see how our medical writers can take the PMS burden from the shoulders of your internal stakeholders!