IVDR Classification: The Seven Rules of Annex VIII and Classes A, B, C and D

The IVDR, Regulation (EU) 2017/746, has been in force since 25 May 2017 and has applied since 26 May 2022 (IVDR Article 113(1) and (2)). It is a regulation, directly applicable in every member state, with 113 articles plus Article 10a and 15 annexes. How the IVDR sits next to the MDR, the second of the two EU medical device regulations, is explained under EU MDR and IVDR.

Below follow the dispute route, the seven rules one by one with the examples of MDCG 2020-16 rev.5, the implementing rules, the duties each class triggers, including the class D checks, and the limits of the guidance.

What Is IVDR Classification?

IVDR classification is the step, set by Article 47 and Annex VIII of Regulation (EU) 2017/746, that assigns an IVD to one of four risk classes, and the class then decides whether a notified body is involved and which reports the manufacturer keeps. The four classes and seven rules took the place of the device lists of the repealed IVDD, as the last main section explains.

Classification therefore comes before the conformity assessment, the post-market surveillance report or periodic safety update report (PSUR) and the summary of safety and performance. The other requirements and deadlines of Regulation (EU) 2017/746 are set out under IVDR (Regulation (EU) 2017/746).

Article 47 and the Four Risk Classes

IVDR Article 47(1) divides devices into classes A, B, C and D, from lowest to highest risk, and Annex VIII sets the rules that place a device in one of them. Annex VIII Section 1 holds the implementing rules 1.1 to 1.10, and Section 2 holds Rules 1 to 7, numbered 2.1 to 2.7; both sections are part of the IVDR text on EUR-Lex. The MDR sorts other medical devices by a different scheme: classes I, IIa, IIb and III under MDR Article 51, set by 22 rules in MDR Annex VIII.

Who Classifies a Device and Who Settles a Dispute

A dispute about the class of an IVD goes to the competent authority (IVDR Article 47(2)). MDCG 2020-16 rev.5 explains how to apply the rules, and notified bodies take MDCG guidance into consideration (IVDR Annex VII Section 1.6.2). The guidance examples on this page help to check a rationale, but ivdrguide.com gives indicative classes only, each with its Annex VIII rule as the legal basis, and never tells a named manufacturer which class its device is in.

The Seven IVDR Classification Rules in One Table

Seven rules in IVDR Annex VIII Section 2 decide the class of an IVD: Rule 1 leads to class D, Rule 2 to class C or D, Rule 3 to class C, Rule 4(a) to class C or B, Rule 5 to class A, and Rules 6 and 7 to class B, while Rule 4(b) classifies near-patient tests in their own right. The table gives each rule with its Annex VIII section, its subject, the resulting class and the examples MDCG 2020-16 rev.5 gives.

The MDR classification rules form a separate system with their own guidance, MDCG 2021-24 rev.1 of April 2026, and their own four classes. The 22 MDR classification rules of Annex VIII are explained rule by rule under MDR classification rules of Annex VIII.

Rules 1 and 2: Transmissible Agents, Blood Grouping and Tissue Typing

Rule 1 puts in class D the devices for detecting transmissible agents in blood, blood components, cells, tissues or organs intended for transfusion, transplantation or cell administration, the devices for life-threatening transmissible agents with a high or suspected high risk of propagation, and the devices for monitoring the infectious load of a life-threatening disease where monitoring is critical. Rule 1 is the only rule whose result is always class D.

Rule 2 covers devices for blood grouping and tissue typing that ensure immunological compatibility: they are class C, and class D where they determine the blood group markers that Rule 2 lists. MDCG 2020-16 rev.5 gives bedside ABO compatibility cards as a class D example under Rule 2, among its Rule 4(b) examples for near-patient tests.

Rule 3: The Class C Purposes, Points (a) to (m)

Rule 3 places in class C the devices for 13 purposes, points (a) to (m) of IVDR Annex VIII Rule 3, among them sexually transmitted agents, infectious agents in cerebrospinal fluid or blood without a high risk of propagation, prenatal screening, cancer, human genetic testing, monitoring of medicinal product levels, management of life-threatening diseases and congenital and newborn screening.

Implementing rule 1.9 gives the higher class to a device that falls under Rule 3 and also under Rule 1 or Rule 2, as the implementing rules section explains. Companion diagnostics are class C under Rule 3(f), and MDCG 2020-16 rev.5 Annex II gives a flowchart to decide whether a device is a companion diagnostic. Their consultation procedure and timelines are covered under companion diagnostics under the IVDR.

Rule 4: Devices Used by Lay Persons or Outside the Laboratory

Rule 4 classifies devices for self-testing in class C, with listed exceptions in class B, under point (a), and classifies devices for near-patient testing in their own right under point (b). Under MDCG 2020-16 rev.5, a device is for self-testing when a lay person performs at least part of the testing procedure; collecting the specimen alone is not self-testing. The guidance examples for both points follow below.

The Class B Exceptions and the Guidance Examples

Self-tests for pregnancy, fertility and cholesterol, and self-tests for glucose, erythrocytes, leucocytes and bacteria in urine, are class B under Rule 4(a). MDCG 2020-16 rev.5 places the HIV self-test in class D, because Rule 1 also applies and implementing rule 1.9 gives the higher class. The table lists the other self-tests and near-patient tests the guidance classifies, by class.

Receptacles and collection kits for lay persons that are sold separately from the testing device are not devices for self-testing (MDCG 2020-16 rev.5, Rules 4(a) and 5(c)). The extra requirements that apply to self-tests and near-patient tests under the IVDR, beyond their class, are set out under self-tests and near-patient tests under the IVDR.

Rules 5, 6 and 7: Laboratory Products, the Fall-Back Rule and Controls

Rule 5 puts in class A general laboratory products and accessories without critical characteristics, buffers, washing solutions, culture media and histological stains, instruments intended for IVD procedures and specimen receptacles, Rule 6 puts every device that Rules 1 to 5 do not cover in class B, and Rule 7 puts controls without an assigned quantitative or qualitative value in class B. MDCG 2020-16 rev.5 lists as class A under Rule 5 products such as H&E and Gram stains, nucleic acid extraction kits, PCR thermocyclers, NGS sequencers and clinical chemistry analysers. The guidance also lists urine cups, stool containers and blood spot cards under Rule 5, and specimen receptacles are class A under Rule 5(c).

Rule 6 is the fall-back rule: a device that none of Rules 1 to 5 covers is class B. Rule 7 is the only rule whose explanation changed in the current revision of the guidance, as the next section shows.

What MDCG 2020-16 rev.5 Changed for Rule 7

MDCG 2020-16 rev.5, dated September 2026 and announced by the Commission on 9 September 2026, changes only Rule 7: it clarifies the rationale and revises the examples. Analyte presence or concentration ranges that the manufacturer of standalone quality control materials provides are not assigned values, so such controls are class B unless another rule applies (MDCG 2020-16 rev.5 on health.ec.europa.eu). A control that does carry an assigned value follows implementing rule 1.6 instead.

Implementing Rules 1.1 to 1.10: Calibrators, Controls and the Highest Class

The 10 implementing rules of IVDR Annex VIII Section 1 govern how the seven rules are applied, among them rule 1.4 on software, rules 1.5 and 1.6 on calibrators and controls with assigned values, and rules 1.8 and 1.9, which give the higher class where more than one intended purpose or rule applies. The five implementing rules and their effect are listed below.

• Rule 1.4: software, covered in the next paragraph.
• Rule 1.5: calibrators with an assigned value, which take the class of the device.
• Rule 1.6: controls with an assigned value, which also take the class of the device.
• Rule 1.8: devices with more than one intended purpose, which take the higher class.
• Rule 1.9: devices that fall under more than one rule, which take the higher class.

IVD software is classified under the IVDR rules and not under MDR Rule 11, as MDCG 2019-11 rev.1 (June 2025) explains. The wording of rule 1.4 and the software examples sit with software under the MDR and IVDR, explained under software under the MDR and IVDR.

Rule 1.10 makes the seven rules apply to first-line, confirmatory and supplemental assays alike. Under rule 1.10, a confirmatory assay is classified by the same rules as the first-line assay for the same purpose, so a confirmatory test for an agent under Rule 1 is class D as well.

What Each Class Triggers: Classes A, B, C and D Compared

The class decides three things under the IVDR: whether a notified body takes part (none for non-sterile class A, IVDR Article 48), whether the manufacturer writes a post-market surveillance report or a PSUR (IVDR Articles 80 and 81), and whether a summary of safety and performance is needed (IVDR Article 29(1)). The table compares the four classes on these three points.

UDI carriers on the label have been mandatory for class D since 26 May 2023 and for classes B and C since 26 May 2025, and become mandatory for class A on 26 May 2027 (IVDR Article 113(3)(e)). These and the other UDI deadlines by class are set out under UDI deadlines by class.

The annex behind each notified-body route, and how far the notified body samples the technical documentation in classes B and C, belong to the conformity assessment route linked in the class A row.

Class D: The Extra Checks for the Highest-Risk Devices

Class D devices, which Rules 1 and 2 produce, carry the extra checks and the legacy end date listed below, and common specifications for certain class D devices have applied since 25 July 2024 under Implementing Regulation (EU) 2022/1107.

• EU reference laboratory verification of the claimed performance and of compliance with the common specifications, where a laboratory is designated (IVDR Article 48(5)); see EU reference laboratories for class D IVDs.
• Expert panel consultation on the performance evaluation report, where no common specifications exist and the type of device is certified for the first time (IVDR Article 48(6)): the class D performance evaluation consultation.
• Notification of class D certificates by the notified body through EUDAMED for scrutiny (IVDR Article 50).
• PSUR review by the notified body, which adds its evaluation (IVDR Article 81(2)).
• Legacy end date of 31 December 2027 for self-declared IVDD devices now in class D, under the conditions of IVDR Article 110 as amended by Regulation (EU) 2024/1860; see IVDR transition periods.

MDCG 2020-16 rev.5: What the Guidance Adds and What It Cannot Do

MDCG 2020-16 rev.5, "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746", is the MDCG's current IVDR classification guidance as of 6 November 2026: it explains the rules with examples, but it is not legally binding (IVDR Articles 98 and 99) and cannot change Annex VIII. The Medical Device Coordination Group (MDCG) issues it, and the Commission lists it under the topic "In Vitro Diagnostic medical devices (IVD)" on its MDCG guidance page. Rev.5 replaced rev.4, so rev.4 is no longer the current text.

The examples on this page, from the HIV self-test in class D to the PCR thermocycler in class A, are the guidance's own, and the class itself always rests on the Annex VIII rule. The other MDCG guidance, sorted by topic, is listed under MDCG guidance by topic.

Before the IVDR: Why the Directive's Lists Gave Way to Rules

Under Directive 98/79/EC (IVDD), repealed from 26 May 2022 except for the provisions IVDR Article 112 keeps, notified-body involvement depended on whether a device appeared in List A or List B of IVDD Annex II or was a device for self-testing (IVDD Article 9). The directive was published in OJ L 331 of 7 December 1998 and remains on EUR-Lex as Directive 98/79/EC.

The IVDR replaced these lists with four risk classes and seven rules, so "List A" and "List B" are IVDD terms and never name an IVDR class. IVDD certificates and declarations still matter for legacy devices, whose end dates follow their IVDR class, as the last question below shows.

The contents of the two lists, the self-test category and the full comparison of the two regimes are covered under IVDD vs IVDR.

Questions on the Four Classes

Four questions come up about the IVDR classes.

Is a home HIV test class C or class D?

Class D: MDCG 2020-16 rev.5 classifies an HIV self-test in class D under Rule 1 together with implementing rule 1.9, although Rule 4(a) alone would give class C. The guidance places the near-patient HIV rapid test in class D under Rule 1 as well.

Does the pending proposal change the seven rules?

No: the Commission's targeted revision, COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), proposes no change to the IVDR Annex VIII classification rules and is pending, at the stage "Awaiting committee decision" in the European Parliament as of 6 November 2026. The proposal would let sterile class A devices go without a notified body and would remove the class D performance evaluation consultation. Its content and stages are tracked under MDR and IVDR amendments.

Which class does a test that selects patients for a medicine get?

Class C: a companion diagnostic is class C under IVDR Annex VIII Rule 3(f). MDCG 2020-16 rev.5 Annex II gives a flowchart to decide whether a device is a companion diagnostic, and a device that also falls under Rule 1 or Rule 2 takes the higher class under implementing rule 1.9.

Which class decides the end date for older devices?

The IVDR class: a self-declared IVDD device now in class D may be placed on the market until 31 December 2027, class C until 31 December 2028, and class B or sterile class A until 31 December 2029, while any device with an IVDD certificate has 31 December 2027, each under the conditions of IVDR Article 110 as amended by Regulation (EU) 2024/1860. Non-sterile class A devices have no transition period.