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.

For this reason, the the Annex XI Production Quality Assurance route is to be combined with the Notified Body’s own independent assessment/testing of an actual device unit(s) via an Annex X “Type Examination” rather than relying only on a paper review of the manufacturer’s design documentation/testing.  The exception to this is lower risk devices (e.g., EU MDR Class IIa and probably also EU IVDR Class B) for which the Production Quality Assurance route can be applied by the manufacturer without NB Type Examination.  So, be sure to remember that if the Annex X Type Examination route is used, then it means that an actual device unit(s) shall be made available to the NB (or its designee) so that the NB can independently do (or arrange for) direct testing/examination of an actual device unit(s) since the NB won’t be engaging in a deep-dive of the manufacturer’s design process.