Conformity assessment procedures under the MDR: Annex IX, Annex X, and Annex XI

The Medical Device Regulation (MDR) 2017/745 provides multiple conformity assessment routes, which depend on the classification of the device, the level of risk, and the manufacturer's existing quality system. The main conformity assessment procedures include:

• Annex IX – conformity assessment based on a Quality Management System and Technical Documentation
• Annex X – conformity assessment ased on type examination
• Annex XI – conformity assessment based on product conformity verification

1. Annex IX – conformity assessment based on a Quality Management System and Technical Documentation

When is Annex IX applicable?

• Class IIa, IIb, and III devices (except custom-made devices).
• Used when the manufacturer has an established Quality Management System (typically aligned with ISO 13485).
• This is the most common conformity assessment route and is applicable when manufacturers wish to demonstrate compliance through a full QMS assessment.

What does Annex IX involve?

• Assessment of the manufacturer’s QMS, including production, final inspection, and post-market surveillance.
• Review of the technical documentation for at least one representative sample per generic device group.
• For Class III devices, the Notified Body reviews the entire technical documentation for each product and issues a Certificate of Conformity.
• For Class IIa and IIb devices, a sampling approach for reviewing technical documentation is applied.

Additional requirements for class III implantable devices:

• Requires an EU Reference Laboratory (EURL) test or Scientific Opinion from an expert panel before certification.

2. Annex X – conformity assessment based on type examination

When is Annex X applicable?

Used in combination with Annex XI for Class III and Class IIb implantable devices. Applicable when manufacturers do not use a full QMS approach or when only specific batches or types of devices require assessment.

What does Annex X involve?

• Examination of the design documentation and test reports.
• Verification that the device meets the MDR requirements.
• Performance of necessary tests or verification procedures.

Once approved, the NB issues a Type Examination Certificate valid for five years.

3. Annex XI – conformity assessment based on product conformity verification

When is Annex XI applicable?

Typically used for Class IIb and III devices. Applied when manufacturers choose to certify individual product batches rather than their full QMS. This is a less common approach, mostly used for high-risk, specialized, or limited-run medical devices.

What does Annex XI involve?

Option A: Product Verification (Full Quality Assurance Not Required)

• The Notified Body examines each product or batch to verify compliance before it is released on the market.
• Ideal for high-risk devices where batch-by-batch verification is necessary.

Option B: Production Quality Assurance

• The Notified Body assesses the manufacturer’s quality assurance system, focusing on final product inspection and testing.
• Ensures that production consistently meets MDR requirements.

Summary of when each annex applies

Conclusion

Annex IX is the preferred route for manufacturers with an established ISO 13485 QMS.

Annex X is used for design-based certification when batch verification is needed.

Annex XI is used for product conformity verification, either through batch testing (Option A) or a production quality assurance system (Option B).

For high-risk Class III devices, the conformity assessment may combine multiple annexes, depending on the device's nature and intended use.