EU IVDR Conformity Assessment Under Article 48: Pathways for All IVD Classes

1. Key takeaways

Article 48 of Regulation (EU) 2017/746 (IVDR) is the gateway that decides how every in vitro diagnostic device reaches the EU market, and it works differently for each class. For Class A non-sterile devices, the route is pure self-declaration: the manufacturer compiles the technical documentation and issues the EU declaration of conformity without any notified body involvement (Article 48(10)). For Class A sterile devices, the manufacturer applies Annex IX or Annex XI, and the notified body is engaged only for the aspects relating to sterile conditions. Class B devices follow Annex IX Chapters I and III, combined with 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)). Class C devices also follow Annex IX Chapters I and III, but the sampling unit widens to at least one representative device per generic device group (Article 48(7)). Class D devices face Annex IX Chapters I, II (except Section 5) and III, plus verification by a European Reference Laboratory (EURL) and, in defined situations, consultation of an expert panel (Articles 48(3) to 48(6)).

Two structural points follow from this. First, the class determines both the conformity assessment route and the sampling granularity, which together drive the number of devices reviewed, the notified body workload and therefore the cost and timeline of the project. Second, Articles 48(4) and 48(8) open an alternative route for Class D and Class C: Annex X type-examination combined with Annex XI production quality assurance. Finally, self-test and near-patient devices attract an additional technical documentation assessment under Section 5.1 of Annex IX, and companion diagnostics must pass through a medicinal product regulatory consultation channel. Every manufacturer should therefore build a route decision table before contacting any notified body.

2. Legal basis

The table below lists the primary legal sources for the conformity assessment pathways under Article 48.

3. Expert insights

Insight 1: the difference between Class B and Class C lies in the sampling unit for representative devices.

Article 48(9) requires, for Class B, at least one representative device per category of devices, while Article 48(7) requires, for Class C, at least one representative device per generic device group. Under Article 2(8), a generic device group is a set of devices having the same or similar intended purpose or a commonality of technology allowing them to be classified generically. The practical consequence is straightforward: moving from Class B to Class C does not merely add one assessment layer, it changes the denominator of the sampling logic. A product line of thirty assay variants may constitute three categories but only one generic device group, or the reverse, depending on how intended purpose and technical commonality are argued. This single definitional exercise directly determines how many technical documentation assessments the notified body will charge for, so it deserves a written justification agreed with the notified body before the application is filed.

Insight 2: self-test and near-patient devices carry an additional documentation assessment.

For Class C and Class D self-test and near-patient devices, the manufacturer must additionally apply the technical documentation assessment procedure of Section 5.1 of Annex IX (second subparagraph of Article 48(3) and second subparagraph of Article 48(7)). Even where usability engineering and instruction-for-use readability are documented in a separate volume, that material falls squarely within the assessment scope. In practice this means the documentation package for such devices cannot simply reuse the standard file set: lay-user comprehension data, error analysis for non-professional use and readable labelling are assessed as distinct subjects. Plan this as a separate work package from the outset.

Insight 3: companion diagnostics must go through the medicinal product consultation channel.

Companion diagnostics (Article 2(7)) in the Class C and Class D routes require the notified body to consult the competent authority of the Member State designated under Directive 2001/83/EC or the EMA, following Section 5.2 of Annex IX (for Class C, for every device) or point (k) of Section 3 of Annex X (for Class D). This channel can significantly extend the timeline, because the consultation runs in parallel with the assessment of the medicinal product concerned. Companion diagnostic projects must therefore be scheduled against the medicinal product registration calendar, not against the IVD project plan alone. Late alignment with the pharmaceutical timetable is one of the most common causes of stalled certification for these products.

Insight 4: Class C and Class D may take the alternative route of Annex X plus Annex XI.

Article 48(4) for Class D and Article 48(8) for Class C allow the manufacturer to switch to a combination of Annex X type-examination and Annex XI production quality assurance. The typical reasons for choosing this route are a small number of device models with large production volumes, or a preference for managing type verification and serial production quality as separate work streams. The trade-off is concentration: type-examination concentrates the sampling and testing burden on the examined specimen, so the preparation of samples, batches and test evidence must be correspondingly tighter. The choice should be made once, at project start, and recorded with reasons.

4. Practical recommendations

The following recommendations turn the route logic of Article 48 into project management actions.

1. Build a route decision table first: class → main route (Annex IX) or alternative route (Annex X + XI) → representative devices and sampling strategy. Record it as a controlled document so the whole project team works from the same assumptions.
2. For Class B and Class C projects, define the boundary of the category of devices and the generic device group early, and obtain written confirmation of the sampling plan from the notified body.
3. Prepare a separate documentation package for self-test and near-patient devices in line with Section 5.1 of Annex IX, covering readability and lay-user error analysis.
4. For companion diagnostics, place the EMA or competent authority consultation node into the overall project plan and align it with the medicinal product timetable.
5. Confirm the language arrangements under Article 48(12): the notified body may require that all or part of the documentation be written in an official language of the Member State where it is established.

5. Verification checklist

Use the checklist below to verify route decisions before filing an application.

• □ The main route and the alternative route have been determined for each class in line with Article 48(3)–(10)
• □ The boundary of the category of devices for Class B and of the generic device group for Class C has been defined
• □ Documentation for self-test and near-patient devices has been prepared per Section 5.1 of Annex IX
• □ The EMA or competent authority consultation node for companion diagnostics has been confirmed (Annex IX Section 5.2 or Annex X Section 3(k))
• □ The applicability of EURL verification and expert panel consultation for Class D has been confirmed (Article 48(5)(6))
• □ Documentation language requirements have been confirmed with the notified body (Article 48(12))

Regulatory information verified as of October 29, 2026.

GRZAN supports IVD manufacturers in the EU market with end-to-end CE certification pathway planning under Regulation (EU) 2017/746. Our team helps you map Article 48 routes for every device class, define categories and generic device groups, structure Annex IX documentation packages and coordinate notified body and EURL interfaces. Whether you face a first IVDR certification or a route migration for an existing portfolio, we provide classification strategy, gap assessment and project scheduling so your conformity assessment proceeds on a realistic timeline. Contact us at info@grzanglobal.com to discuss your EU IVDR programme.