Annex III of the MDR is cited less often than Annex II, but it is just as mandatory. It defines the technical documentation relating to manufacturing — a distinct component that complements Annex II to form the complete technical documentation.
The difference between Annex II and Annex III
Annex II describes the device: what it is, what it is used for, how it was designed, tested and clinically evaluated. Annex III describes how it is manufactured: the processes, the equipment, the in-process controls.
The two are complementary and inseparable. A technical documentation comprising only Annex II without Annex III is incomplete.
The content of Annex III
Annex III comprises two parts.
Part A — Information on the manufacturer and the manufacturing system.
Description of the manufacturing premises and the equipment used, covering all sites involved, including subcontractors for critical steps.
Description of the manufacturing processes: each transformation step, the control parameters, the in-process control points, the specifications of the final controls.
Identification of components and raw materials, of qualified suppliers, and of the supply specifications with the acceptance criteria upon receipt.
For special processes (sterilisation, welding, critical moulding), the validation documentation is expected here, with reference to the detailed results kept in the QMS.
Part B — Final sterilisation and sterile packaging processes.
If the device is supplied sterile, the validation documentation for sterilisation and sterile packaging must be included: validation protocols, results of the IQ/OQ/PQ phases, validated process parameters, and the results of the routine controls.
Consistency with the ISO 13485 QMS
This is the point that notified bodies systematically verify during a combined QMS and technical documentation audit: the consistency between what is described in Annex III and the procedures actually in force in the QMS.
A process described in Annex III that has evolved without an update to the technical documentation constitutes a non-conformity with the obligation to maintain the technical documentation (Article 10(4) MDR). This is a frequent gap in SMEs that develop their manufacturing processes without systematically integrating the documentary impact on the technical documentation.
Regulatory source: Annex III of Regulation (EU) 2017/745 — EUR-Lex