April 20, 2023
EU MDR/IVDR Annex IX Full QMS vs. Annex XI Production Quality Assurance
The assessment of the full QMS via Annex IX includes (among other things) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices and the corresponding documentation as well as the data and records arising from those procedures and techniques [EU MDR Annex IX.2.2(d) and IVDR Annex IX.2.2(c)]. In other words, Annex IX includes assessment of the integrity of the manufacturer’s device design process and results.
In contrast, an Annex XI “Production Quality Assurance” assessment of the QMS does not include the EU MDR Annex IX.2.2(d) / IVDR Annex IX.2.2(c) design process assessment (that’s not a typo; certain Annex IX elements are incorporated by reference into Annex XI). In other words, the Production Quality Assurance route does not directly include assessment of the integrity of the manufacturer’s design process.