In-Vitro-Diagnostics

Post-Market Surveillance IVDs

An essential goal of the restructured certification requirements for in vitro diagnostics in Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR) for the European economic region lies in securing product safety throughout the whole life cycle, especially also within the framework of potentially shifting demands, questions and challenges. Central elements are, besides the establishment of a post-market surveillance (PMS) system (Article 78), extended obligations for documentation and reporting of surveillance features, for example the PMS plan (Article 79 und Annex III, section I) and the PMS report (Article 80). For products of class C and class D, a Periodic Safety Update Report (PSUR) needs to be compiled, which has to be updated every year. As part of the PMS system, in general the performance needs to be monitored regularly during the entire life cycle of a product (Article 56.6), as specified in a Post-Market Performance Follow-up (PMPF) plan (Annex XIII, part B) and described in a PMPF report.

We will be happy to prepare the necessary documents, like PMS & PMPF plan and/or PMS report and PSUR, respectively, as well as the PMPF report according to the current regulation (IVDR) and MDCG guidances for a successful validation by your Notified Body.

Please send your inquiry to the following address: medicaldevice@ebeling-assoc.com