EU IVDR Class B Conformity Assessment: Annex IX Chapters I and III

1. Key takeaways

Class B devices (other than devices for performance study) must follow Chapters I and III of Annex IX, combined with an assessment of the technical documentation of at least one representative device per category of devices under Sections 4.4 to 4.8 of Annex IX (Article 48(9)). Self-test and near-patient Class B devices must additionally undergo the technical documentation assessment procedure under Section 5.1 of Annex IX.

Class B is the volume class of the IVDR transition. Rule 6 of Annex VIII places every device not covered by a preceding rule in Class B, which captures the large population of routine diagnostic assays that were self-declared under the legacy regime. These products now require a notified body, and the resulting queue pressure makes early filing and a well-organised documentation package decisive for the project timeline. Two levers dominate the workload and cost: how the category of devices is defined, which fixes how many representative devices must be assessed, and how the surveillance cycle under Chapter III of Annex IX is organised around change management.

2. Legal basis

The table below lists the primary legal sources for the Class B pathway.

3. Expert insights

Insight 1: the quality management requirements for Class B differ in intensity from Class C and D.

Article 48(9) requires only Chapters I and III of Annex IX for Class B; Class C likewise requires Chapters I and III (Article 48(7)); Class D requires Chapters I, II (except Section 5) and III (Article 48(3)). Chapter II corresponds to the general requirements on the assessment of technical documentation, which for Class B and Class C are delivered through the sampled assessments under Sections 4.4 to 4.8. The practical reading is that Class B projects concentrate their documentation effort on the sampled representative devices and the QMS itself, rather than producing full Chapter II assessment material for every model. Understanding this structure prevents both under-scoping and over-producing documentation.

Insight 2: the definition of the category of devices directly determines the number of assessments and the cost.

Article 48(9) uses the category of devices as the sampling unit. A definition that is too narrow, treating every model as its own category, multiplies the number of assessments and the fees; a definition that is too wide may be rejected by the notified body as insufficient to cover the differences between devices. The workable method is to argue sameness along three dimensions, intended purpose, technological principle and key performance characteristics, and to secure written confirmation of the resulting grouping from the notified body. Treat this grouping as a controlled document, because it governs the sampling logic for the entire certificate cycle.

Insight 3: Class B self-test and near-patient products are assessed separately.

Under Article 2(5), self-test devices are intended for use by lay persons; under Article 2(6), near-patient devices are used by health professionals outside a laboratory environment. In Class B, both must undergo the additional technical documentation assessment under Section 5.1 of Annex IX, and the assessment focus typically lies on the readability of the instructions for use and on the risks of erroneous use by non-professional users. Lay-user comprehension testing, clear result interpretation support and mitigation of user errors should therefore be part of the documentation from the start, not added after the notified body raises them.

Insight 4: Class B is the landing class for most legacy self-declared products.

Rule 6 of Annex VIII assigns any device not covered by the preceding rules to Class B. The routine diagnostic reagents that were self-declared under the legacy regime fall here in large numbers, which makes Class B the class with the greatest transition volume and the heaviest notified body queue pressure in the legacy conversion programmes. Slot availability, not document drafting, is often the binding constraint for these projects, so an early application and a pre-agreed sampling plan are the most effective schedule-protection measures available.

4. Practical recommendations

The following actions keep Class B projects moving despite queue pressure.

1. Define the category of devices with a three-dimensional table covering intended purpose, technological principle and key performance, and obtain written confirmation from the notified body.
2. Organise the documentation package for each representative device according to Sections 4.4 to 4.8 of Annex IX, and avoid submitting the documentation of the whole product family at once, which can block the assessment queue.
3. Prepare a separate Section 5.1 package for self-test and near-patient products, including readability validation and lay-user comprehension testing.
4. Plan the surveillance cycle under Chapter III of Annex IX and link surveillance audits to the change management process, so that design or process changes are assessed before the next audit rather than discovered during it.
5. Track possible implementing acts under Article 48(13) on sampling frequency and minimum frequencies for unannounced audits, and update the surveillance plan when they arrive.

5. Verification checklist

Confirm the following points before filing a Class B application.

• □ The applicability of Annex IX Chapters I and III has been confirmed under Article 48(9)
• □ The category of devices has been defined and at least one representative device per category has been identified
• □ The documentation of the representative devices has been organised per Sections 4.4 to 4.8 of Annex IX
• □ Self-test and near-patient products have been supplemented with documentation per Section 5.1 of Annex IX
• □ Written confirmation of the sampling plan has been obtained from the notified body
• □ Surveillance audits (Annex IX Chapter III) are linked to change management

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers in the EU market with CE certification pathway and classification strategy under Regulation (EU) 2017/746. For Class B portfolios we help you define device categories, build Section 4.4–4.8 documentation packages, prepare Section 5.1 material for self-test products and manage notified body queue planning. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.