EU MDR Conformity Assessment Procedures: Which Route for Your Device?

You're in a meeting. Someone asks: "Which conformity assessment procedure do we need for this device?"

You pause. You know it depends on device classification. You think Annex IX is the standard route, but you've heard colleagues mention Annex XI for certain devices. The MDR lists multiple pathways, and the consequences of choosing wrong are significant - months of delay, rejected submissions, wasted Notified Body fees.

This guide gives you the decision framework the regulation doesn't spell out clearly.

The Decision Framework: Class Determines Route

Why this matters: Your device class isn't just a regulatory label - it determines your entire conformity assessment pathway, Notified Body involvement level, and documentation requirements.

The MDR offers manufacturers choices, but those choices narrow based on device risk classification. Here's the decision tree that actually determines your route.

Most manufacturers default to Annex IX because it's the "standard" route mentioned first in MDR Article 52. But Annex XI exists for good reason - it offers flexibility for manufacturers with product families or frequent design variations.

Annex IX: Quality Management System Route

Why this matters: Annex IX is the most common route for a reason - it's designed for manufacturers with established quality systems and multiple device types. Understanding its two chapters prevents submission errors.

Annex IX has two chapters, and which one applies depends on your device class and risk profile.

Here's what "representative sampling" actually means in Chapter III: The Notified Body doesn't review every device variant. They select devices that represent your technology, risk profile, and design approaches. If you have 50 catheter variants, they might review 5-8 representative designs.

Annex XI: Type Examination + Production QA Route

Why this matters: Annex XI splits conformity assessment into two parts - product approval first (Type Examination), then production quality approval. This matters when you have design variations or want faster market access for new product versions.

Annex XI works differently. Instead of assessing your entire QMS upfront, the Notified Body first examines a specific device type (Type Examination - Annex X), then verifies your production process can consistently manufacture that approved type.

After Type Examination, you choose one of two production verification routes:

Most manufacturers choose Part A (Production QA) because Part B's batch-by-batch verification becomes expensive at scale. But Part B makes sense for truly custom devices or very low production volumes where ongoing surveillance isn't cost-effective.

What the Notified Body Actually Assesses

Why this matters: Knowing what assessors actually look for during audits prevents the most common certification delays. These aren't theoretical requirements - these are the questions your assessment team will ask.

Notified Body assessments aren't abstract. They follow MDR Annex VII requirements and focus on specific evidence. Here's what they're actually checking.

The most common misconception: manufacturers think Notified Body audits check whether you have the required documents. They actually check whether those documents prove you're consistently applying the processes they describe.

Assessment reports focus on objective evidence. "We have a procedure for X" isn't sufficient - assessors want to see records showing that procedure was followed for actual devices currently on the market.

Common Mistakes That Delay Certification

After analyzing conformity assessment submissions, three mistakes appear repeatedly and cost manufacturers months of delay.