IVDR (EU) 2017/746: in vitro diagnostic medical devices

Author Hugues Orgitello Last updated 27 May 2026 ~17 min read

Guide · IVDR

Regulation (EU) 2017/746, known as the IVDR (In Vitro Diagnostic Regulation), governs the placing on the market and putting into service of in vitro diagnostic medical devices in the European Union. Adopted in April 2017 alongside its twin text the MDR and applicable since 26 May 2022, the IVDR replaces Directive 98/79/EC (IVDD) and represents the deepest overhaul of the in vitro diagnostic regime since the introduction of the medical CE marking. Its logic mirrors that of the MDR on the cross-cutting pillars, traceability via UDI, the European EUDAMED database, post-market surveillance, but it adds mechanisms specific to diagnostics, in particular an entirely new risk-based classification, systematic Notified Body involvement for most devices and, for class D, examination by EU reference laboratories.

Why the IVDR replaced the IVDD

Directive 98/79/EC was one of the oldest texts of the European medical device framework, and the most permissive. It rested on a largely declarative logic, in which the overwhelming majority of in vitro diagnostic devices were placed on the market by manufacturer self-certification, with no Notified Body involvement. Only a few categories listed in Annex II of the IVDD (for example screening tests for HIV or hepatitis C intended for transfusion use) were subject to third-party assessment. The European Commission consistently estimated the proportion of self-declared devices at around 80 to 90 percent of the marketed inventory.

This regime had two structural weaknesses. First, it was out of step with how diagnostic practice had evolved. Between 1998 and 2015, in vitro diagnostics moved from a largely manual activity to one heavily automated, software-driven and based on new biomarkers (genetics, oncology, high-sensitivity cardiac markers). The risk attached to an incorrect test result, especially in a mass-screening context, turned out to be far higher than the IVDD had anticipated. Second, the PIP breast implant scandal in 2010 and the broader recognition of the limits of the medical CE marking led the European Commission to launch a simultaneous overhaul of the MDR and the IVDR.

Regulation (EU) 2017/746 was adopted on 5 April 2017, published in the Official Journal on 5 May 2017, and has been fully applicable since 26 May 2022 (with transitional arrangements detailed below). See the MDR guide for its counterpart on general medical devices.

Scope: what is an IVD device

Article 2(2) of the IVDR defines an in vitro diagnostic medical device as any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, and intended to provide information on one or more of:

• a physiological or pathological process or state,
• a congenital physical or mental impairment,
• a predisposition to a medical condition or a disease,
• the determination of safety and compatibility with potential recipients,
• the prediction of treatment response or reactions,
• the definition or monitoring of therapeutic measures.

Specimen receptacles (tubes, collection vials, transport media) and devices intended for use in genetic diagnostic testing are also covered. Article 2(2) clarifies that a device is also an IVD when intended for self-testing (consumer tests) or near-patient testing (point-of-care, POC).

The boundary with the MDR runs through the presence or absence of an in vitro examination of a human specimen. A device that measures a physiological parameter directly on the patient (sphygmomanometer, oximeter, ECG) falls under the MDR. A device that analyses a sample extracted from the patient (blood, urine, saliva, tissue, sputum) falls under the IVDR. An analyser that combines collection and analysis may raise borderline questions, addressed by MDCG guidances.

Software is explicitly included. Software intended to interpret or process data from an in vitro examination (for example a PCR curve interpretation algorithm, an NGS sequencing analysis engine, an immunohistochemistry scoring system) is an IVD device under the IVDR.

Classification by rules, Annex VIII

This is the most significant change compared to the IVDD. The IVDR introduces a four-tier classification, founded on two risk axes, individual patient risk and public health risk. Annex VIII contains seven rules (rules 1 to 7) that result in a class A, B, C or D outcome.

Class	Individual risk	Public health risk	Typical examples
A	Low	Low	General laboratory reagents, general culture media, general laboratory instruments, specimen receptacles (non-sterile), buffer solutions
A sterile	Low	Low	Same categories as class A, supplied sterile (sterile collection tubes for instance)
B	Moderate	Low	Pregnancy tests, specific quality controls, total cholesterol measurement, glucose outside diabetic self-monitoring, common renal function markers
C	High OR	Moderate OR	Tumour markers (PSA, CA-125, CA 19-9), screening tests for sexually transmitted infections on individual specimens outside blood donation, predisposition genetic tests, diabetes and thyroid function self-tests, HPV tests, HIV and hepatitis self-tests
D	High AND	High AND	Transfusion screening for blood-borne pathogens (HIV, HCV, HBV, HTLV) on blood donations, HLA typing for transplantation, ABO and Rh blood grouping on donations, screening for emerging high-epidemic-risk transmissible agents

The Annex VIII rules operate by successive exclusion, from the highest risk down. Rule 1 covers class D, rule 2 covers class C in transfusion-related contexts that fall short of class D criticality, the following rules step down toward classes B and A. Rule 6 is the residual rule, any device not covered by the previous rules falls into class B.

Two specific cases deserve mention. First, self-tests (devices intended for the general public, in pharmacies or direct sale) are up-classified by at least one class through rule 4. A self-test for HIV is not class B but class C. Second, companion diagnostics intended to identify a patient's eligibility for a specific therapy are class C by rule 3, on account of their direct coupling with a therapeutic decision.

See the self-declaration vs Notified Body guide for the cross-cutting framework and the glossary for IVDR terms (EU reference laboratory, performance evaluation, performance study, etc.).

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Conformity assessment routes by class

The IVDR conformity routes are defined in Annexes IX, X and XI. The general principle is that the class governs the level of Notified Body involvement and the presence or absence of diagnostics-specific additional steps.

Class	Base route	Notified Body involvement	IVD specificity
A non-sterile	Annex II + EU declaration of conformity by the manufacturer	None	Self-declaration, as in the MDR for unsubcategorised class I
A sterile	Annex IX restricted to sterility aspects, or Annex XI part A restricted to the same aspects	NB for sterility only	No IVD-specific layer beyond sterility
B	Annex IX chapters I and III	NB, QMS audit + sampled technical documentation review by generic device group	Performance evaluation embedded in the documentation
C	Annex IX chapters I and III, with extended technical documentation review by sampling per generic category	NB, full audit + in-depth technical documentation review	Reinforced performance evaluation, documented performance studies
D	Annex IX chapters I, II and III (design dossier review for each device), or Annex X (EU-type examination) + Annex XI (batch verification)	NB, full design dossier review + batch verification	Specimens and documentation submitted to the designated EU reference laboratory

Three remarks deserve attention.

First, unlike the IVDD where the default class was self-declaration, under the IVDR the default class is class B (via the residual rule), which requires a Notified Body. That inversion is the structural shift of the regime and the main source of pressure on IVDR Notified Bodies since 2022.

Second, for class D the IVDR adds two mechanisms that exist neither for the other classes nor in the MDR. Batch verification (Annex XI) requires that each batch produced be verified either by the Notified Body or by the manufacturer under an approved quality system with records transmitted to the NB. And the EU reference laboratory designated for the pathogen or target concerned receives specimens of the device and the associated documentation and issues an opinion transmitted to the Notified Body. The manufacturer does not pay this service directly, but implementing acts foresee contributions. The list of EU reference laboratories designated by disease or family of targets is maintained by the European Commission.

Third, in-house tests developed by a hospital laboratory or clinical laboratory benefit from a partial exemption (Article 5(5) of the IVDR), under strict documented conditions, when the device is not commercialised beyond the health institution, when no CE-marked commercial equivalent is available and when the justification is recorded in the laboratory's quality management system. This exemption has been the subject of successive adjustments and remains a regulatory watch point.

The IVDR Notified Body shortage

The IVDR applied to Notified Bodies a joint assessment regime comparable to the MDR. Each candidate NB must be redesignated under the IVDR by its own designating authority, after a joint audit involving the European Commission and the member state assessment team. The process is slow. As with the MDR, the living list of IVDR-designated Notified Bodies is maintained in the Commission's NANDO database, and that list has ramped up progressively since 2018.

The practical effect is more acute than for the MDR, because the share of devices subject to third-party assessment has grown sharply (from 10-20 percent to roughly 80-90 percent, the exact mirror of the IVDD situation). Engagement timeframes with an IVDR Notified Body were identified by the Commission, as soon as the regulation became applicable in 2022, as a major risk for the continued supply of clinically essential tests. That is the direct cause of the two successive extensions of the transitional timeline (see below).

Without citing precise figures that move quickly, the live reference remains NANDO, which lists at any given time the IVDR NBs with their detailed scope by class and device category.

Performance evaluation and performance studies

Article 56 and Annex XIII of the IVDR establish a Performance Evaluation (PE) framework, the diagnostic equivalent of the MDR's clinical evaluation. The PE is structured around three pillars that must be demonstrated independently and then articulated together in a Performance Evaluation Report (PER).

• Scientific Validity (SV). Is the analyte measured (protein, nucleic acid, antibody, metabolite, cellular marker) associated with the targeted clinical condition (disease, physiological state, predisposition)? The demonstration typically rests on consensus scientific literature, clinical guidelines, public knowledge bases (Cosmic, ClinVar for genetic variants), or proprietary data when the manufacturer introduces a novel marker.
• Analytical Performance (AP). Does the device correctly measure the targeted analyte? The characterised parameters are trueness, precision (repeatability and reproducibility), analytical sensitivity (limit of detection LoD, limit of quantification LoQ), analytical specificity (interferences, cross-reactions), linearity, measurement range and stability. The reference methodology draws extensively on CLSI documents (Clinical and Laboratory Standards Institute) and equivalent ISO standards (ISO 17511 for metrological traceability).
• Clinical Performance (CP). Is the device result relevant to the clinical decision in the target population? The characterised parameters are clinical sensitivity, clinical specificity, positive and negative predictive values (PPV and NPV), positive and negative likelihood ratios, and where relevant the area under the ROC curve. Studies use cohorts representative of the indication population.

Where existing data (literature, post-market, equivalence with a device already CE-marked under the IVDR) are insufficient, the manufacturer must run a Performance Study (PS). Article 58 distinguishes three types of studies, interventional studies on subjects, studies using residual samples, and performance studies involving specific specimens. Interventional studies and certain categories on specific specimens require authorisation by the national competent authority and an ethics committee opinion. All studies are registered in EUDAMED, in the dedicated module.

For class D devices and certain class C categories, the Notified Body consults the expert panel foreseen by Article 48, mirroring Article 54 of the MDR for innovative class III implants.

Unique Device Identification (UDI) and EUDAMED

The IVD UDI is aligned on the MDR UDI. Articles 24 to 30 of the IVDR set out the obligations, structuring into UDI-DI and UDI-PI, marking on the device and on the packaging, registration in EUDAMED. The same issuing agencies are recognised, GS1, HIBC, ICCBBA, plus IFA for Germany.

EUDAMED is the common database for the MDR and the IVDR. Article 30 of the IVDR cross-refers to the MDR provisions. The six functional modules (actors, devices, notified bodies and certificates, performance studies and clinical investigations, vigilance, market surveillance) cover both families, with specific sub-sections for performance studies. The modular rollout and the sequencing of mandatory use of each module were realigned by Regulation (EU) 2024/1860, which clarified the timeline and removed the uncertainty that had weighed on EUDAMED's pace.

Instructions for use (IFU) and labelling

IFU and labelling requirements are set out in Annex I section 20 of the IVDR. They are aligned on the MDR for the general principles (official language of each member state where transcription is required, UDI identifier, CE marking accompanied by the NB number for classes B/C/D, identification of the manufacturer and where applicable the authorised representative) and include sections specific to diagnostics, notably the claimed performance, storage and transport conditions, stability, known interferences, known limitations and special precautions for the operator.

For self-tests, reinforced requirements apply: instructions intended for a non-professional user, information on result interpretation, a clear statement of the need for confirmation by a healthcare professional, guidance on handling positive and negative results, and an obligation to offer user support.

The IVDD to IVDR transition: where we stand in 2026

The IVDR transition is arguably the most intricate in the European medical package, because it has been amended twice in response to the assessed Notified Body capacity proving insufficient against the volume of devices to be reassessed.

The original timetable set the general date of application at 26 May 2022. Recognising as early as 2022 that the IVDR NBs could not absorb the inflow of files, the European Commission and the Parliament rapidly adopted Regulation (EU) 2022/112, which amended Article 110 of the IVDR to phase deadlines by class, allowing more time to the least critical classes. This first extension proved insufficient, and Regulation (EU) 2024/1860 carried out a second extension, lengthening the deadlines further while clarifying the EUDAMED status in parallel.

Device category	IVDD extension deadline (amended text)
Class D under IVDD or new class D devices	31 December 2027
Class C under IVDD or new class C devices	31 December 2028
Class B under IVDD	31 December 2029
Sterile class A under IVDD	31 December 2029

These dates derive from Article 110 of the IVDR as amended by Regulation (EU) 2024/1860 and are conditional on several criteria that the manufacturer must meet, notably an active application with an IVDR Notified Body before the class-specific switch-over deadline, a formal contract signed with that NB, the maintenance of an equivalent IVDR quality management system during the transition, and the absence of any substantial change to the device during the transition. The detail of the conditions is set out in the associated MDCG guidances.

See the certification timeline for project planning and the CE page for the general CE marking framework.

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IVDR versus IVDD: what changed

The table below summarises the structural differences between the two texts. It does not replace reading the articles themselves, which should be consulted when positioning a concrete device.

Dimension	IVDD 98/79/EC	IVDR (EU) 2017/746
Legal form	Directive (national transposition)	Regulation (direct application)
Classification	List in Annex II, the rest self-declared	Classes A, B, C, D via Annex VIII rules
Self-declared share	About 80 to 90 percent of the market	Only non-sterile class A
Notified Body	For a few listed categories	From sterile class A, generalised from class B
Performance evaluation	Limited demonstration, variable vocabulary	Structured PE on SV + AP + CP, documented PER, framed performance studies
EU reference laboratory	Non-existent	Designated by pathogen or target, mandatory involvement for class D
Batch verification	For certain Annex II categories	For the whole of class D, Annex XI
UDI	Non-existent	Mandatory, Articles 24 to 30
EUDAMED	Non-existent	European database shared with the MDR
PMS	Limited	PMS system, PSUR for classes C and D, PMS report for classes A and B
Authorised representative	Defined but lightly framed	Article 11 with dedicated PRRC, explicit liability

IVDR versus MDR: a twin regime, with differences

The IVDR and the MDR were drafted together and share a common architecture. That said, the differences are structural, and a manufacturer who masters the MDR does not automatically master the IVDR.

Dimension	MDR (EU) 2017/745	IVDR (EU) 2017/746
Device family	General medical devices (instruments, implants, software, etc.)	In vitro diagnostic devices (reagents, analysers, kits, interpretation software)
Classification	I, IIa, IIb, III, 22 rules in Annex VIII	A, B, C, D, 7 rules in Annex VIII
Risk pivot	Duration, invasiveness, energy autonomy	Individual risk + public health risk
Batch verification	Not systematic	Mandatory for class D
EU reference laboratories	No	Yes for class D
Expert panel	Article 54, innovative class III implants	Article 48, class D and certain class C categories
Evaluation	Clinical evaluation (CER)	Performance evaluation (PER)
Field studies	Clinical investigations	Performance studies
EUDAMED	Common database	Common database
UDI	Aligned	Aligned
PSUR cadence	Annual (IIb and III), biennial (IIa)	Annual (D), biennial (C)
Transitional timeline	Regulation (EU) 2023/607	Regulations (EU) 2022/112 and (EU) 2024/1860

IVD software and the AI Act interaction

Rule 1 of Annex VIII of the IVDR governs IVD devices intended to provide information on physiological or pathological processes. That rule applies to IVD software when it has a proper diagnostic purpose. As with rule 11 of the MDR, the effect is up-classification of diagnostic decision-support software, which moves quickly into class C or even D depending on the criticality of the clinical result and on the transfusion or non-transfusion context.

An NGS sequencing interpretation software for the detection of somatic variants in oncology, for example, is typically class C. A serology interpretation software for transfusion screening of blood-borne pathogens would be class D, with the attendant implications (software batch verification assimilated to version verification, EU reference laboratory involvement, see the specific MDCG guidances).

The AI Act, Regulation (EU) 2024/1689, applies in parallel when the software embeds an artificial intelligence system. An IVD software classified B/C/D under the IVDR is considered, under the AI Act, a high-risk AI system. The application is cumulative: the manufacturer must demonstrate conformity with both the IVDR and the AI Act, without either replacing the other. IVDR conformity does not waive AI Act-specific obligations on training data governance, transparency toward the professional user, decision logging and AI-specific post-market follow-up. Regulation (EU) 2024/1689 includes provisions to avoid duplicate audits by relying on existing sectoral notified bodies, including IVDR NBs.

See the CE pillar for the general CE marking framework and the glossary for IVDR term definitions (PE, PS, PER, SV, AP, CP, EU reference laboratory, etc.).

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Common pitfalls observed in the field

Without claiming exhaustiveness, several recurring patterns appear in MDCG guidances, in industry feedback and in Notified Body communications.

• Assuming IVDD self-certification ports across mechanically. This is probably the most frequent pitfall. A manufacturer who placed a serology test on the market by self-declaration under the IVDD cannot maintain it under the same regime under the IVDR. The A/B/C/D classification must be redone from Annex VIII, and the outcome is very often a move into class B or C, hence Notified Body involvement.
• Late engagement with a Notified Body for class C or D. Given the limited capacity of IVDR NBs, lead times are long. A manufacturer waiting for the final year of the transitional period to engage the file risks finding no NB available within the deadlines, and therefore having to withdraw the device from the European market.
• Overlooking batch verification for class D. Batch verification (Annex XI) is specific to IVDR class D and has no direct counterpart under the MDR. It must be designed into the quality management system and the production process from the outset.
• No engagement with the EU reference laboratory designated for the target. For class D, going through the EU reference laboratory is mandatory. The manufacturer must identify the laboratory designated for the pathogen or category of targets concerned and plan specimen and documentation submission. This step is often underestimated in the schedule.
• Performance evaluation limited to analytical performance. A compliant PE covers the three pillars (SV + AP + CP). A demonstration limited to analytical performance, without documented scientific validity and without clinical performance characterised on a representative cohort, is a frequent non-conformity.
• In-house tests treated as a general escape route. The Article 5(5) exemption is strictly conditional. An in-house test diffused beyond the health institution loses the exemption and falls into the full IVDR regime. The boundary must be held rigorously in the laboratory's quality management system.
• Software classified too low, through an optimistic reading of rule 1 of Annex VIII. The rule raises the class as soon as a critical clinical result is at stake, particularly in transfusion and oncology contexts.

The AESTECHNO scope on IVD devices

AESTECHNO is an electronics and embedded systems design house, not a medical regulatory affairs firm. Pilot work on an IVDR file proper (A/B/C/D classification, performance evaluation, articulation with the Notified Body and the EU reference laboratory) sits outside the AESTECHNO scope and requires a consultant or a firm specifically positioned on in vitro diagnostics.

For the electronics portion of an in vitro diagnostic instrument (motherboard, analytical chemistry motor control, connectivity, power supply, user interface, EMC and RED conformity where applicable), a design review is feasible within the limits of a standard electronics file. This page is an editorial reference published by spilma.com, of which AESTECHNO is the editor.

See also

• FDA 510(k), De Novo and PMA: US medical devices
• QMS: ISO 9001, AS 9100, ISO 13485, TL 9000 compared
• IATF 16949: automotive quality management
• Risk management: ISO 14971, IEC 31010, FMEA, FTA, HAZOP

Working on the electronics portion of an in vitro diagnostic instrument for a real product? AESTECHNO can audit your design and certification plan. Get in touch →

Where this overview leads

This page is a cross-cutting overview. The dedicated pages that complement this guide cover or will cover in depth:

• detailed classification by rule (Annex VIII of the IVDR, rule by rule),
• IVD software and rule 1 (IMDRF framework, specific MDCG guidances),
• performance evaluation and the PER (Annex XIII, MDCG 2022-2),
• performance studies (Article 58, national authorisations),
• class D and the EU reference laboratories,
• the IVDD to IVDR transition (amended Article 110, Regulations (EU) 2022/112 and 2024/1860),
• the general medical devices counterpart, see the MDR guide.

Sources & references

1. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) , EUR-Lex eur-lex.europa.eu/eli/reg/2017/746/oj
2. Regulation (EU) 2022/112, first extension of IVDR transitional provisions , EUR-Lex eur-lex.europa.eu/eli/reg/2022/112/oj
3. Regulation (EU) 2024/1860, second IVDR extension and EUDAMED obligations , EUR-Lex eur-lex.europa.eu/eli/reg/2024/1860/oj
4. MDCG guidance documents (Medical Device Coordination Group) , European Commission health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
5. EUDAMED, the European database on medical devices , European Commission ec.europa.eu/tools/eudamed/
6. NANDO, notified bodies designated under IVDR , European Commission ec.europa.eu/growth/tools-databases/nando/
7. EU reference laboratories for class D IVD devices , European Commission health.ec.europa.eu/medical-devices-topics-interest/eu-reference-laboratories_en