Are You Over Committing on Your EU MDR Post Market Surveillance Plan?
The EU MDR and IVDR will usher in increased post market surveillance (PMS) requirements for all MedTech companies, mandating a PMS plan that includes a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is not required. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR), while for lower-class devices, a [...]