March 24, 2023

EU MDR: Who Must Hold the Annex XI Part A Certificate?

In addition to a production-focused quality management system certificate(s) (e.g., EU Quality Assurance Certificate or EU Product Verification Certificate), the EU MDR Annex XI Part A conformity assessment route requires the “manufacturer“, depending on device class, to also hold an:

• EU Technical Documentation Assessment Certificate (Class IIa devices), or

• EU Type-Examination Certificate (Class IIb and Class III devices).

Even if the “manufacturer” (the one named and identified as such on the device label) has outsourced the fabrication process to a contract manufacturing site, it still remains the obligation of the “manufacturer” to obtain and maintain the EU Technical Documentation Assessment Certificate (Class IIa devices) or EU Type-Examination Certificate (Class IIb and Class III devices).  Such a contract manufacturer is not required to hold its own EU Technical Documentation Assessment Certificate (Class IIa devices) or EU Type-Examination Certificate.