EU IVDR Classification under Annex VIII: Four Risk Classes A to D

1. Key takeaways

The IVDR divides in vitro diagnostic devices into four risk classes: A, B, C and D (Article 47(1)). Classification is based on the intended use of the device and its inherent risk, and the operative rules sit in Annex VIII, which consists of 10 implementation rules (1.1 to 1.10) and 7 classification rules (Rules 1 to 7). Where the manufacturer and the notified body disagree on classification, the matter is referred under Article 47(2) to the competent authority of the Member State in which the manufacturer has its registered place of business.

Classification is not an academic exercise. It determines whether a notified body is involved at all, which conformity assessment route under Article 48 applies, how deep the technical documentation review goes, and therefore the certification timeline and cost structure. Because Article 47(3) allows the Commission to reclassify devices through implementing regulations, classification conclusions must also be monitored over time rather than frozen once determined.

2. Legal basis

The table below lists the provisions governing classification and its consequences for conformity assessment.

Note that the classification framework and the conformity assessment framework are deliberately coupled: Article 47 decides the class, and Article 48 converts the class into an assessment route. Any classification argument should therefore be drafted with the Article 48 consequence in view.

3. Expert insights

Insight 1: the four classes are a two-dimensional scale of individual risk and public health risk.

The European Commission’s explanatory material on the IVDR describes the classes as follows: Class A covers low individual risk and low public health risk; Class B covers moderate individual risk and/or low public health risk; Class C covers high individual risk and/or moderate public health risk; and Class D covers high individual risk and high public health risk. Classification does not look at technical difficulty; it looks at what happens if the result is wrong. A technically sophisticated product with a benign failure mode can land in a lower class than a simple product whose failure could kill a patient, and teams should argue from consequences, not from engineering complexity.

Insight 2: classification directly determines whether a notified body is needed.

Class A devices that are not sterile are self-declared by the manufacturer under Article 48(10). Class A sterile devices require notified body involvement, but limited to the establishment, assurance and maintenance of the sterile conditions. Classes B, C and D all require a notified body under Articles 48(3) to 48(9). Being wrong by one class changes the entire certification cycle and cost structure: a product self-declared as Class A but correctly Class B needs an assessment route, a quality management system audit and a notified body contract, none of which appear in a Class A plan.

Insight 3: the classification conclusion must be documented, and revisited on change.

Article 47(1) requires classification according to intended use, and Annex VIII implementation rule 1.1 reiterates that the application of the rules is governed by the intended purpose. Consequently, once indications, specimen types or use settings are extended, the classification must be re-argued. Implementation rules 1.8 and 1.9 settle how to proceed where there are multiple intended purposes or where several rules compete: the class that yields the higher classification applies. A classification rationale that is not version-controlled alongside the intended-use statement will drift out of alignment silently.

Insight 4: the Commission can override the outcome of Annex VIII.

Article 47(3)(b) allows the Commission, on the basis of new scientific evidence or information from vigilance or market surveillance activities, to reclassify a device or a device group through an implementing act, by way of derogation from Annex VIII. Classification is therefore not a one-time static conclusion. Implementing acts at Commission level must be tracked, because a reclassification can move an entire product line overnight and trigger a new conformity assessment route for devices already on the market.

4. Practical recommendations

1. Build a classification rationale table for every device entry: intended-use wording, applicable rule, resulting class, and the location of the supporting evidence.
2. For devices used in combination, classify each device separately under implementation rule 1.2; do not issue a single merged judgment.
3. For platform products, list the instrument, reagents, calibrators, control materials and accessories item by item and file each under its own classification record.
4. Where the notified body’s classification opinion differs, follow the referral procedure under Article 47(2) to the competent authority and retain all correspondence.
5. Re-verify once per year whether the intended use, the applicable harmonised standards or any Commission implementing acts have changed (as a practical estimate).

5. Verification checklist

• □ A class conclusion has been reached for every device entry under Article 47(1) and Annex VIII
• □ The classification rationale table records the intended-use wording and the applicable rule numbers
• □ Combination devices and accessories have been handled separately under implementation rules 1.2 and 1.3
• □ Multiple intended purposes and competing rules have been resolved upward under rules 1.8 and 1.9
• □ Classification conclusions have been carried through to the Article 48 route selection and the structure of the technical documentation
• □ An annual re-verification mechanism is in place (as a practical estimate)

Regulatory information verified as of 29 October 2026.

GRZAN advises manufacturers on IVDR classification under Annex VIII, prepares defensible classification rationale tables, and manages referral discussions with competent authorities and notified bodies where classification outcomes are contested. For tailored compliance support on the EU IVDR market, contact info@grzanglobal.com.