April 3, 2023

Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1

The MDR/IVDR PMS procedures and blank templates for the PMS Plan should be Tier 2 generic quality management system (QMS) documents (i.e., procedures), while the actual PMS Plan should instead be a device-specific Tier 4 QMS document (i.e., a record).  This is in alignment with standard conventional QMS documentation practice.  Indeed, since PMS is a key component driven by the QMS requirements prescribed by EU MDR QMS Articles 10(9/10) / IVDR QMS Articles 10(8/9), then we should employ conventional QMS when approaching MDR/IVDR PMS.  For example, the notified body BSI says that, “…Please note that the [Post Market Surveillance] procedure is not the same as the Plan – the former refers to the manufacturer’s quality system requirements and is generic to all devices marketed by a manufacturer, whereas the latter is specific to the subject device, and can only be generated in light of data from the clinical evaluation and risk evaluation for that device…”