What is the difference between IVDR and MDR?

Both regulations were adopted on 5 April 2017 and published together. The MDR, Regulation (EU) 2017/745, covers general medical devices; the IVDR, Regulation (EU) 2017/746, covers in vitro diagnostic devices: reagents, calibrators, controls, kits, instruments and software intended to examine specimens taken from the human body. They share EUDAMED, UDI and the notified body framework, but the IVDR has its own seven classification rules, a performance evaluation in place of the clinical evaluation, and, for class D, batch verification and EU reference laboratories.

How is a diagnostic test classified A, B, C or D?

Annex VIII has seven rules. Rule 1 puts in class D tests that screen donations for transmissible agents, detect agents of life-threatening diseases with a high risk of propagation, or measure the infectious load of a life-threatening disease where monitoring is critical. Rule 2 puts blood grouping and tissue typing in class C, except ABO, Rhesus, Kell, Kidd and Duffy markers, which are class D. Rule 3 lists thirteen class C purposes, among them sexually transmitted agents, companion diagnostics, cancer and human genetic testing. Rule 4 makes self-tests class C, with class B exceptions. Rule 5 is class A (general laboratory products, instruments, specimen receptacles). Rule 6 sends everything else to class B, and rule 7 puts controls without an assigned value in class B.

Are glucose self-tests class B?

Only urine glucose. Rule 4 makes self-tests class C, except devices for pregnancy, fertility, cholesterol, and "glucose, erythrocytes, leucocytes and bacteria in urine", which are class B. A blood glucose meter for self-testing is therefore class C.

When is a notified body needed under the IVDR?

For every class except non-sterile class A. Sterile class A involves a notified body only for sterility. Classes B and C go through the quality management system route of Annex IX with technical documentation sampled per category (B) or per generic device group (C), and every self-test or near-patient test has its own technical documentation assessed. Class D adds technical documentation assessment for every device, batch verification, EU reference laboratory testing where a laboratory has been designated, and expert panel consultation where there are no common specifications and it is the first certification of that type of device.

What are the IVDD transition deadlines in 2026?

Under Article 110 as rewritten by Regulation (EU) 2024/1860, devices with a valid IVDD notified body certificate may be placed on the market until 31 December 2027. Devices that were self-declared under the IVDD but need a notified body under the IVDR have until 31 December 2027 (class D), 31 December 2028 (class C) and 31 December 2029 (class B and sterile class A). Each date depends on conditions: a quality management system by 26 May 2025, a formal application to a notified body by 26 May 2025, 2026 or 2027, and a signed written agreement by 26 September 2025, 2026 or 2027, by class. For class C, both of those 2026 dates have passed.

Is EUDAMED mandatory for IVD devices?

Yes, for four modules. Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed that the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules were functional, so their use became mandatory on 28 May 2026. Under the IVDR provisions added by Regulation (EU) 2024/1860, manufacturers have six months from that date to register devices already on the market that are still placed on the market, and notified bodies twelve months to enter certificates. The vigilance and performance study modules follow later.

Does diagnostic software fall under the IVDR?

Software intended to provide information from the in vitro examination of specimens is an IVD. Its class is set by implementing rule 1.4 of Annex VIII: software that drives or influences a device takes that device's class, and stand-alone software is classified in its own right under rules 1 to 7, according to its intended purpose. There is no IVDR rule equivalent to MDR rule 11. MDCG 2019-11 covers software qualification and classification under both regulations.

Can AESTECHNO support an IVDR file?

No. AESTECHNO is an electronics and embedded systems design house. The IVDR file, from classification to performance evaluation and notified body review, needs a regulatory affairs consultant specialised in IVD devices. For the electronics of an IVD instrument (boards, connectivity, power, user interface, EMC), a design review is feasible, but the IVDR file itself is outside its scope.

IVDR 2017/746: classes A to D and the 2027-2029 deadlines

Hugues Orgitello updated 7 Oct 2026 11 min read

The IVDR, Regulation (EU) 2017/746, has applied to in vitro diagnostic devices since 26 May 2022, but 2026 is the year it caught up with most of the market. EUDAMED became mandatory on 28 May 2026. The class C transition had two deadlines this year: 26 May for applying to a notified body and 26 September for signing with one. And the AI Act deadline for diagnostic software moved to August 2028. This guide works from the regulation's text: the seven classification rules as written, the conformity route each class triggers, the transition conditions of Regulation (EU) 2024/1860 date by date, and the readings of the IVDR that the text does not support.

TL;DR:

Annex VIII has seven rules; most devices end up in class B by default (rule 6), so most need a notified body.
Only non-sterile class A is self-declared. Class D adds batch verification, EU reference laboratory testing and, in some cases, an expert panel.
Legacy devices: IVDD certificates until 31 December 2027; self-declared IVDD devices until 2027 (D), 2028 (C) or 2029 (B and sterile A), each subject to application and agreement deadlines.
EUDAMED: mandatory since 28 May 2026 for four modules; legacy devices still placed on the market must be registered within six months.

The 2026 calendar

Date	What happens	Text
26 May 2022	IVDR applies	IVDR Article 113
10 January 2025	Duty to warn of supply interruptions at least 6 months ahead	Article 10a, inserted by 2024/1860
26 May 2025	Legacy devices: QMS in place; formal application for IVDD-certified and class D devices	Article 110(3c)
26 September 2025	Written agreement with a notified body for IVDD-certified and class D devices	Article 110(3c)(f)
26 May 2026	Formal application deadline for legacy class C devices	Article 110(3c)(e)(ii)
28 May 2026	Four EUDAMED modules mandatory	Commission Decision (EU) 2025/2371
26 September 2026	Written agreement deadline for legacy class C devices	Article 110(3c)(f)(ii)
28 November 2026	Legacy devices still placed on the market registered in EUDAMED (six months after 28 May 2026)	Article 113(3)(fa)
26 May 2027	Formal application deadline for legacy class B and sterile class A	Article 110(3c)(e)(iii)
26 September 2027	Written agreement deadline for legacy class B and sterile class A	Article 110(3c)(f)(iii)
31 December 2027	End for IVDD-certified devices and legacy class D	Article 110(3a), (3b)(a)
2 August 2028	AI Act high-risk obligations for AI in Annex I products, IVDs included	AI Act as amended by the Digital Omnibus
31 December 2028	End for legacy class C	Article 110(3b)(b)
31 December 2029	End for legacy class B and sterile class A	Article 110(3b)(c)
31 December 2030	In-house devices: the "no equivalent device on the market" justification applies	Article 5(5)(d), Article 113(3)(j)

Scope

Article 2(2) defines an IVD as any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body, including blood and tissue donations, to provide information on a physiological or pathological process or state, a congenital impairment, a predisposition, safety and compatibility with potential recipients, the prediction of treatment response, or the definition or monitoring of therapeutic measures. Specimen receptacles are IVDs too.

The boundary with the MDR is the specimen. A device that measures the patient directly (pulse oximeter, ECG) is under the MDR; a device that examines a specimen taken from the patient is under the IVDR. Software that interprets data from an in vitro examination, such as a PCR curve analysis or an NGS variant caller, is an IVD.

The seven classification rules, as written

Rule	Class	What it covers
1	D	Transmissible agents in blood, cells, tissues or organs to assess suitability for transfusion, transplantation or cell administration; transmissible agents causing a life-threatening disease with a high or suspected high risk of propagation; infectious load of a life-threatening disease where monitoring is critical to patient management
2	C, or D	Blood grouping and tissue typing for transfusion, transplantation or cell administration: class C, except ABO, Rhesus (RH1 to RH5, RHW1), Kell (K), Kidd (Jka, Jkb) and Duffy (Fya, Fyb) markers, which are class D
3	C	Thirteen purposes, (a) to (m): sexually transmitted agents; infectious agents in CSF or blood without high propagation risk; infectious agents where an error could cause death or severe disability; prenatal immune status; infective or immune status where an error leads to a life-threatening decision; companion diagnostics; disease staging with life-threatening error; cancer screening, diagnosis or staging; human genetic testing; monitoring of medicinal products or substances with life-threatening error; management of life-threatening diseases; congenital disorders in the embryo or foetus; congenital disorders in new-born babies
4	C, or B	Self-tests are class C, except pregnancy, fertility, cholesterol, and glucose, erythrocytes, leucocytes and bacteria in urine, which are class B. Near-patient tests are classified in their own right
5	A	General laboratory products, buffer and washing solutions, general culture media and histological stains; instruments intended for IVD procedures; specimen receptacles
6	B	Everything not covered by rules 1 to 5
7	B	Controls without a quantitative or qualitative assigned value

The implementing rules in section 1 of Annex VIII matter as much as the rules. Calibrators and controls with assigned values take the class of the device they are used with (1.5, 1.6). Accessories are classified in their own right (1.3). If several rules apply, the highest class wins (1.9), and the rules apply equally to first-line, confirmatory and supplemental assays (1.10). Software that drives or influences a device takes its class; stand-alone software is classified in its own right (1.4).

Conformity routes by class (Article 48)

Class	Route	What the notified body does
A, non-sterile	EU declaration of conformity after technical documentation (Annexes II and III)	Nothing
A, sterile	Annex IX or Annex XI	Sterility aspects only
B	Annex IX chapters I and III	QMS assessment; technical documentation of at least one representative device per category of devices
C	Annex IX chapters I and III, or Annex X plus Annex XI (without section 5)	QMS assessment; technical documentation of at least one representative device per generic device group
D	Annex IX chapters I, II (except section 5) and III, or Annex X plus Annex XI	Technical documentation of every device; batch verification; EU reference laboratory testing where designated; expert panel where Article 48(6) applies

Three add-ons cut across classes:

Self-tests and near-patient tests in classes B, C and D: technical documentation assessment under Annex IX section 5.1, device by device.
Companion diagnostics in classes C and D: the notified body consults the medicines competent authority or the EMA (Annex IX section 5.2).
Class D batch verification (Annex IX sections 4.12 and 4.13, Annex XI section 5): the manufacturer tests every batch, sends the reports to the notified body and makes samples available, including to the EU reference laboratory where one is designated. The batch may be placed on the market unless the notified body decides otherwise within the agreed time, and no later than 30 days after receiving the samples.

EU reference laboratories

For class D devices covered by a designated EU reference laboratory, the notified body must ask one of them to verify the claimed performance by laboratory testing, focusing on analytical and diagnostic sensitivity (Article 48(5)). Commission Implementing Regulation (EU) 2023/2713 designated the first five laboratories, in Germany, Spain and Sweden, for hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses that cause life-threatening diseases. They have been active since 1 October 2024. A class D device outside those categories is assessed without a laboratory until one is designated.

Expert panels

Under Article 48(6), the notified body consults the expert panel on the performance evaluation report only when there are no common specifications for that class D device and it is the first certification for that type of device. It is not a routine step for class C or for every class D device.

Performance evaluation and performance studies

Article 56 and Annex XIII require a performance evaluation built on three elements, each documented in the performance evaluation report:

Scientific validity: the analyte is associated with the clinical condition or physiological state.
Analytical performance: trueness, precision, analytical sensitivity and specificity, measuring range, interference and cross-reactivity.
Clinical performance: diagnostic sensitivity and specificity, predictive values and likelihood ratios in the intended population.

Article 58(1) sets out which performance studies need authorisation and full study rules: those with surgically invasive sample-taking done only for the study, interventional clinical performance studies, and studies whose conduct involves additional invasive procedures or other risks for the subjects. Companion diagnostic studies follow the same rules, unless they use only left-over samples, in which case they are notified to the competent authority (Article 58(2)). All performance studies need scientific and ethical review (Article 58(3)).

Post-market surveillance

Class	Report	Cadence
A and B	Post-market surveillance report (Article 80)	Updated when necessary
C and D	Periodic safety update report (Article 81)	At least annually; class D PSURs go to the notified body through EUDAMED

Transition: what Regulation (EU) 2024/1860 actually requires

The extended dates come with five cumulative conditions (Article 110(3c)). The device must continue to comply with the IVDD; there must be no significant change in design or intended purpose; it must present no unacceptable risk; the manufacturer must have a QMS under Article 10(8) by 26 May 2025; and it must meet the application and agreement dates for its class.

Legacy device	Placing on the market until	Formal application by	Written agreement by
IVDD notified body certificate, valid on 26 May 2022	31 December 2027	26 May 2025	26 September 2025
Self-declared under IVDD, class D under IVDR	31 December 2027	26 May 2025	26 September 2025
Self-declared under IVDD, class C under IVDR	31 December 2028	26 May 2026	26 September 2026
Self-declared under IVDD, class B or sterile class A under IVDR	31 December 2029	26 May 2027	26 September 2027

Two details are often missed. The application can be for the legacy device or a device intended to substitute it, so a redesign can benefit from the transition. And IVDR rules on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply to legacy devices from the start (Article 110(3d)).

In-house devices

Article 5(5) exempts devices manufactured and used only within health institutions established in the Union from the IVDR, except the general safety and performance requirements of Annex I, under cumulative conditions: no transfer to another legal entity, manufacture and use under an appropriate quality management system, a laboratory compliant with EN ISO 15189 or national provisions, information to the competent authority on request, a public declaration, and fuller documentation for class D devices. Point (d), the justification that the target patient group's needs cannot be met, or not at the appropriate level of performance, by an equivalent device on the market, applies only from 31 December 2030 (Article 113(3)(j), as amended by Regulation (EU) 2024/1860). Even then, a CE-marked equivalent does not close the exemption if it cannot meet those needs at the right level of performance.

Software and the AI Act

IVD software is classified through implementing rule 1.4 and the ordinary rules: a variant interpretation tool for cancer is class C under rule 3(h), software interpreting donor screening results is class D under rule 1. There is no IVDR counterpart of MDR rule 11.

When the software includes an AI system and the IVD needs a notified body, the AI Act treats it as high-risk under Article 6(1), because the IVDR is listed in Annex I. The Digital Omnibus amending the AI Act, in force since late July 2026, moved the high-risk obligations for AI in Annex I products to 2 August 2028, and gives the Commission power to limit AI Act requirements where sectoral legislation already imposes equivalent ones.

Readings the text does not support

Common reading	What the text says
"Glucose self-tests are class B"	Only glucose in urine; blood glucose self-tests are class C (rule 4(a))
"Rule 1 governs IVD software, like MDR rule 11"	Software is classified by implementing rule 1.4; rule 1 is about transmissible agents
"HLA typing is class D"	Rule 2: tissue typing is class C; class D is reserved for the listed ABO, Rhesus, Kell, Kidd and Duffy markers
"The expert panel reviews class C and class D devices"	Article 48(6): class D only, without common specifications, first certification of that type
"Batch verification is Annex XI only"	Annex IX sections 4.12 and 4.13 and Annex XI section 5; the 30-day cut-off is in both
"The transition just requires an IVDR application"	Five cumulative conditions, including a QMS by 26 May 2025 and a signed agreement by a class-specific date

IVDR versus MDR

Dimension	MDR (EU) 2017/745	IVDR (EU) 2017/746
Classes	I, IIa, IIb, III; 22 rules	A, B, C, D; 7 rules
Risk axis	Invasiveness, duration, active energy	Individual risk and public health risk
Evaluation	Clinical evaluation	Performance evaluation
Studies	Clinical investigations	Performance studies
Batch verification	Not general	Class D
EU reference laboratories	No	Class D, where designated
PSUR	IIb and III annually, IIa at least every two years	C and D at least annually
Software rule	Rule 11	Implementing rule 1.4 and rules 1 to 7
Transition texts	Regulations (EU) 2023/607 and 2024/1860	Regulations (EU) 2022/112 and 2024/1860

See the MDR guide for its counterpart and the self-declaration vs notified body guide for the cross-cutting picture.

Common pitfalls

Carrying an IVDD self-declaration into the IVDR. Reclassify from Annex VIII; most devices land in class B or C.
Missing a 2026 class C date. Without an application by 26 May 2026 and an agreement by 26 September 2026, a legacy class C device cannot use the extension to 2028.
Forgetting EUDAMED for legacy devices. Devices still placed on the market need registration within six months of 28 May 2026.
Analytical performance without clinical performance. Annex XIII requires all three elements.
Ignoring rule 4. A self-test version of a class B professional test usually moves to class C, and every self-test has its technical documentation assessed.
Treating in-house tests as an open door. Article 5(5) applies only to devices kept within the health institution under documented conditions.

The AESTECHNO scope on IVD devices

AESTECHNO is an electronics and embedded systems design house, not a medical regulatory affairs firm. The IVDR file proper (classification, performance evaluation, notified body and EU reference laboratory) is outside its scope and needs a consultant specialised in IVD devices. For the electronics of an IVD instrument (boards, motor control, connectivity, power, user interface, EMC), a design review is feasible. This page is an editorial reference published by spilma.com, of which AESTECHNO is the editor.

Frequently asked questions

What is the difference between IVDR and MDR?: Both regulations were adopted on 5 April 2017 and published together. The MDR, Regulation (EU) 2017/745, covers general medical devices; the IVDR, Regulation (EU) 2017/746, covers in vitro diagnostic devices: reagents, calibrators, controls, kits, instruments and software intended to examine specimens taken from the human body. They share EUDAMED, UDI and the notified body framework, but the IVDR has its own seven classification rules, a performance evaluation in place of the clinical evaluation, and, for class D, batch verification and EU reference laboratories.
How is a diagnostic test classified A, B, C or D?: Annex VIII has seven rules. Rule 1 puts in class D tests that screen donations for transmissible agents, detect agents of life-threatening diseases with a high risk of propagation, or measure the infectious load of a life-threatening disease where monitoring is critical. Rule 2 puts blood grouping and tissue typing in class C, except ABO, Rhesus, Kell, Kidd and Duffy markers, which are class D. Rule 3 lists thirteen class C purposes, among them sexually transmitted agents, companion diagnostics, cancer and human genetic testing. Rule 4 makes self-tests class C, with class B exceptions. Rule 5 is class A (general laboratory products, instruments, specimen receptacles). Rule 6 sends everything else to class B, and rule 7 puts controls without an assigned value in class B.
Are glucose self-tests class B?: Only urine glucose. Rule 4 makes self-tests class C, except devices for pregnancy, fertility, cholesterol, and "glucose, erythrocytes, leucocytes and bacteria in urine", which are class B. A blood glucose meter for self-testing is therefore class C.
When is a notified body needed under the IVDR?: For every class except non-sterile class A. Sterile class A involves a notified body only for sterility. Classes B and C go through the quality management system route of Annex IX with technical documentation sampled per category (B) or per generic device group (C), and every self-test or near-patient test has its own technical documentation assessed. Class D adds technical documentation assessment for every device, batch verification, EU reference laboratory testing where a laboratory has been designated, and expert panel consultation where there are no common specifications and it is the first certification of that type of device.
What are the IVDD transition deadlines in 2026?: Under Article 110 as rewritten by Regulation (EU) 2024/1860, devices with a valid IVDD notified body certificate may be placed on the market until 31 December 2027. Devices that were self-declared under the IVDD but need a notified body under the IVDR have until 31 December 2027 (class D), 31 December 2028 (class C) and 31 December 2029 (class B and sterile class A). Each date depends on conditions: a quality management system by 26 May 2025, a formal application to a notified body by 26 May 2025, 2026 or 2027, and a signed written agreement by 26 September 2025, 2026 or 2027, by class. For class C, both of those 2026 dates have passed.
Is EUDAMED mandatory for IVD devices?: Yes, for four modules. Commission Decision (EU) 2025/2371, published on 27 November 2025, confirmed that the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules were functional, so their use became mandatory on 28 May 2026. Under the IVDR provisions added by Regulation (EU) 2024/1860, manufacturers have six months from that date to register devices already on the market that are still placed on the market, and notified bodies twelve months to enter certificates. The vigilance and performance study modules follow later.
Does diagnostic software fall under the IVDR?: Software intended to provide information from the in vitro examination of specimens is an IVD. Its class is set by implementing rule 1.4 of Annex VIII: software that drives or influences a device takes that device's class, and stand-alone software is classified in its own right under rules 1 to 7, according to its intended purpose. There is no IVDR rule equivalent to MDR rule 11. MDCG 2019-11 covers software qualification and classification under both regulations.
Can AESTECHNO support an IVDR file?: No. AESTECHNO is an electronics and embedded systems design house. The IVDR file, from classification to performance evaluation and notified body review, needs a regulatory affairs consultant specialised in IVD devices. For the electronics of an IVD instrument (boards, connectivity, power, user interface, EMC), a design review is feasible, but the IVDR file itself is outside its scope.