The PMS of your medical devices must be carefully planned and documented. This is required not only by the MDR but by several MDCG guidelines and ISO/TR 20416 as well. The PMS and the separate PMCF plan describe how data should be collected and evaluated. Notified bodies check both documents during the quality management system audit.
Our services include the evaluation of your PMS data, which are processed and statistically evaluated with our proven novineon CRO methodology. We then create a trend report and summarize the results in a report. The MDR requires a PMS report for class I products and a regularly updated PSUR (Periodic Safety Update Report) for higher risk classes. Due to the modularity of our approach, these reports can be directly integrated into the clinical evaluation.
|Risk class||Type of report||Frequency||Addressee||Evaluation|
|I||PMS report||as needed||responsible authority upon request||–|
|IIa||PSUR||as needed, at least yearly||notified body + responsible authority upon request||–|
|IIb||PSUR||yearly||notified body + responsible authority upon request||–|
|III/Implant||PSUR||yearly||notified body + EUDAMED||Evaluation by notified body; report + evaluation to responsible authority|
- Pragmatic and compact summary of all necessary activities and methods in a PMS plan
- Data preparation and evaluation
- Creation and updating of PMS report or PSUR
Contact your novineon specialist.
Phone: +49 7071 98979 – 127