Understanding MDR Annex IX. Conformity assessment based on a Quality Management System and Technical Documentation

Annex IX of the Medical Device Regulation 2017/745 defines the conformity assessment process for medical devices based on a Quality Management System and Technical Documentation review. This is one of the most commonly used pathways for obtaining CE certification, particularly for manufacturers that already have an ISO 13485-compliant QMS in place.

Annex IX is divided into three chapters, each covering different aspects of the conformity assessment process. These chapters determine how manufacturers demonstrate compliance with MDR requirements based on the risk classification of the device, the complexity of its design, and the manufacturer’s existing quality assurance processes.

Chapter I: Quality Management System assessment

The first chapter outlines the general requirements for manufacturers implementing and maintaining a Quality Management System. The Notified Body (NB) must assess the QMS to ensure compliance with MDR provisions, covering aspects such as:

• Design, manufacturing, and final product inspection
• Risk management procedures
• Post-market surveillance and vigilance system
• Technical documentation maintenance

The QMS must ensure compliance with the General Safety and Performance Requirements (GSPR) of MDR. Manufacturers are required to demonstrate that their devices are consistently manufactured and controlled according to these standards.

Chapter I is applicable to:

• Class IIa, IIb, and III devices where a full QMS-based approach is preferred
• Manufacturers seeking a comprehensive assessment of their production and design controls
• Companies that require periodic audits and ongoing surveillance by a Notified Body

This assessment is not applicable to Class I devices unless they require Notified Body involvement (such as for sterile or measuring functions).

Chapter II: assessment of Technical Documentation

The second chapter focuses on the technical documentation review by the Notified Body. This is a critical step in ensuring that the device meets performance, safety, and regulatory compliance requirements under MDR.

The Notified Body examines elements such as:

• Device description and specifications
• Risk management procedures and clinical evaluation
• Verification and validation data
• Post-market surveillance planning

For Class IIa and IIb devices, the Notified Body assesses technical documentation using a sampling approach, meaning not every single file is reviewed. However, for Class III devices, the Notified Body must review each individual device and its full technical documentation.

Chapter II applies to:

• Manufacturers of Class IIa, IIb, and III devices that require technical documentation assessment
• Devices that have undergone significant design modifications requiring reassessment
• High-risk Class III devices, where all documentation must be reviewed before certification

This chapter does not apply to Class I devices, as they are self-certified by the manufacturer unless they involve special conditions like sterilization or measuring functions.

Chapter III: administrative provisions

The third chapter of Annex IX details the administrative processes that govern the interactions between manufacturers, Notified Bodies, and regulatory authorities. This includes:

• Surveillance and unannounced audits to ensure continued compliance with the approved QMS
• Certificate modifications and validity periods
• Manufacturer obligations regarding documentation updates
• Rules for withdrawing or suspending certificates in cases of non-compliance

Chapter III applies to:

• All manufacturers undergoing conformity assessment under Annex IX
• Companies seeking certificate renewals or making changes to their approved QMS
• Notified Bodies performing periodic audits and market surveillance activities

This chapter ensures that manufacturers maintain compliance even after obtaining their CE certification by requiring continued monitoring, corrective actions for non-conformities, and re-evaluation of the certification if significant changes occur.

When is Annex IX the preferred route?

Annex IX is the most commonly used conformity assessment procedure under MDR, particularly for manufacturers with an ISO 13485-compliant QMS. It is preferred when:

• A comprehensive QMS-based approach is required for certification
• The manufacturer regularly updates technical documentation and requires ongoing Notified Body oversight
• The device falls under Class IIa, IIb, or III, requiring Notified Body involvement in the conformity assessment
• The manufacturer wants a single conformity assessment route covering both QMS and technical documentation

Conclusion

Annex IX of MDR provides a structured approach for medical device manufacturers to demonstrate compliance through a Quality Management System assessment and Technical Documentation review. The three chapters of this annex define different levels of assessment, from evaluating the manufacturer’s quality procedures and risk management to ensuring compliance through continuous Notified Body oversight.