Can Class B and C devices avoid notified body review of their technical documentation?

No. A common misconception is that Class B and C devices only need QMS certification without technical documentation scrutiny, but Annex IX Section 2.3 requires the notified body to sample technical documentation even for these classes. Class D and certain high-risk categories receive full, rather than sampled, technical documentation review.

How much has notified body involvement expanded compared to the old IVDD regime?

Under the IVDD roughly 20 percent of IVDs required notified body involvement, whereas under the IVDR that figure exceeds 80 percent because risk-based classification rules pull far more devices into Class B, C, and D. This shift is one of the primary drivers of the IVDR transition backlog.

What additional obligations apply on top of the standard route for Class D devices?

Class D devices carry extra duties under Article 48(3) to (6) beyond the base conformity assessment route, including EU Reference Laboratory batch verification where designated, Common Specifications scrutiny, and, for novel devices, mandatory expert-panel consultation. Overlooking these add-on requirements is a frequent cause of certification delay for the highest-risk IVDs.

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IVDR Conformity Assessment Routes

The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

Articles 48 to 50 map conformity assessment to device class. Class A (non-sterile) is self-declared. Class A sterile, B, and C follow Annex IX (quality management system plus technical documentation assessment) or Annex X (type examination) combined with Annex XI (production quality assurance). Class D requires Annex IX with notified body scrutiny plus, where applicable, EU Reference Laboratory batch verification and Common Specifications compliance.

What the regulation says

Article 48(1) requires manufacturers to draw up an EU declaration of conformity following the conformity assessment procedure appropriate to the class of the device.

What this means in practice

Under the IVDD roughly 20 percent of IVDs required notified body involvement; under IVDR that figure exceeds 80 percent. Choosing between Annex IX and X+XI is largely a QMS design decision: Annex IX aligns with ISO 13485 full-scope certification, while Annex X+XI splits type examination from production oversight.

Examples

A manufacturer of a Class A non-sterile IVD, such as a general laboratory reagent for a non-critical test, will use a self-declaration of conformity based on Article 50 of the IVDR.
A company developing a Class C IVD for detecting a specific infectious disease antigen would typically apply Annex IX, demonstrating a robust quality management system and undergoing technical documentation assessment by a notified body.
For a Class D IVD for blood donor screening, the manufacturer must adhere to Annex IX, including notified body assessment, and additionally comply with relevant Common Specifications and potentially undergo EU Reference Laboratory batch verification.

Common pitfalls

•Assuming Class B and C can skip notified body review for technical documentation. Sampling per Annex IX Section 2.3 applies.
•Overlooking the extra Class D duties in Article 48(3) to (6): EU RL batch testing, CS scrutiny, expert-panel consultation for novel devices.

Frequently asked questions

For Class A sterile, B, and C devices, manufacturers can choose Annex IX (quality management system assessment plus technical documentation review) or Annex X (type examination) combined with Annex XI (production quality assurance). The choice is largely a QMS design decision: Annex IX aligns with a full-scope ISO 13485 certification, while Annex X plus XI separates the type examination of a representative device from ongoing production oversight.

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Editor's picks

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EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

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IVDR Risk Classes A–D

EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).

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Notified Body(NB)

EU-designated organization that assesses conformity of medical devices under MDR and IVDR.

Standards

ISO 13485

International standard for medical device quality management systems.

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The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class.

·Under the IVDD roughly 20 percent of IVDs required notified body involvement; under IVDR that figure exceeds 80 percent.
·Choosing between Annex IX and X+XI is largely a QMS design decision: Annex IX aligns with ISO 13485 full-scope certification, while Annex X+XI splits type examination from production oversight.
·Class A (non-sterile) is self-declared.

Remember this

Watch out: Assuming Class B and C can skip notified body review for technical documentation. Sampling per Annex IX Section 2.3 applies.

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