Manufacturers of Class I Devices, a report summarizing the results of the analysis of the post-market surveillance data collected and the outputs based on these results, along with the rationale and explanation of each preventive and corrective action taken.
In order to carry out the process, first of all, a PMS Plan should be established by taking into account MDR Chapter VII Article 84 and Annex III.
The PMS Process performed in accordance with the PMS Plan should be recorded in its entirety in the PMS Report for Class I Products.