In Vitro Diagnostic Regulation (EU) 2017/746

Last reviewed: May 2026 · Legal status verified against EUR-Lex.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices — the "IVDR" — replaces Directive 98/79/EC and covers tests and devices used in vitro for the examination of human specimens (blood, tissue, urine, saliva). It was adopted alongside the Medical Devices Regulation 2017/745 and entered into force on 26 May 2017. Its date of application was 26 May 2022, but the transitional period for legacy devices was extended substantially by Regulation (EU) 2024/1860 and earlier Regulation (EU) 2022/112 in response to severe Notified Body capacity constraints. The IVDR was published in the OJEU as OJ L 117, 5.5.2017, p. 176.

Legal status and timeline

• Adoption: 5 April 2017.
• Entry into force: 26 May 2017.
• Date of application: 26 May 2022.
• Transitional periods (as amended by Regulation (EU) 2024/1860):
  • Class D devices: until 31 December 2027;
  • Class C devices: until 31 December 2028;
  • Class B and Class A sterile devices: until 31 December 2029;
  • "In-house" devices manufactured and used within the same health institution: from 26 May 2024 (with certain Article 5(5) conditions met).
• Status in May 2026: applies; legacy IVDD-certified devices continue under the conditions of Regulation 2022/112 and 2024/1860.

The IVDR's transitional regime is unusually long because, unlike the MDD/MDR transition, the predecessor IVDD allowed approximately 80% of IVDs to be self-declared. The IVDR pushes most of those into classes requiring a Notified Body, and Notified Body capacity for IVDR did not exist when the Regulation began to apply.

Scope: products covered

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, piece of 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". The purpose must be solely or principally:

• To provide information about a physiological or pathological process or state;
• To provide information about congenital physical or mental impairments;
• To provide information about the predisposition to a medical condition or a disease;
• To determine the safety and compatibility with potential recipients;
• To predict treatment response or reactions;
• To define or monitor therapeutic measures.

Examples include laboratory analysers, PCR kits, blood-grouping reagents, glucose self-test devices, pregnancy tests, HIV/SARS-CoV-2 antibody tests, and companion diagnostics. The Regulation extends explicitly to "companion diagnostics" — IVDs essential for the safe and effective use of a specific medicinal product (Article 2(7)) — and to genetic testing.

Risk classification (Annex VIII)

The IVDR classifies IVDs into four classes A through D according to a rule-based system in Annex VIII:

• Class A — Low individual and low public health risk. Examples: laboratory instruments not used for medical decisions, specimen receptacles. Subdivided into Class A sterile (Notified Body required for sterility aspects) and Class A non-sterile (self-declaration).
• Class B — Moderate individual or low public health risk. Examples: pregnancy tests, urine analysis reagents.
• Class C — High individual or moderate public health risk. Examples: blood glucose self-monitoring, infectious disease tests not in Class D, genetic tests, companion diagnostics.
• Class D — High individual and high public health risk. Examples: HIV, hepatitis B/C/D, HTLV, syphilis, malaria detection in blood transfusion or transplantation contexts; tests for transmissible agents in blood, tissue, or organs.

For Class C and D devices, conformity assessment requires Notified Body involvement under Annex IX (full quality management system + technical documentation assessment), Annex X (type-examination), or Annex XI (production quality assurance). Class D devices additionally require involvement of an EU Reference Laboratory (Article 100) and consultation with expert panels for specific clinical evidence requirements.

Essential requirements (Annex I)

Annex I sets the general safety and performance requirements, structured similarly to Annex I of the MDR but adapted for IVDs:

• Chapter I — General requirements (points 1–8): risk management, intended use, benefit-risk analysis.
• Chapter II — Requirements regarding performance, design, and manufacture (points 9–20): scientific validity, analytical performance, clinical performance, chemical and physical properties, infection control, software requirements, devices for self-testing and near-patient testing.
• Chapter III — Requirements regarding information supplied with the device (point 20): label and instructions for use, requirements for self-testing devices.

Performance evaluation

Articles 56–58 and Annex XIII require a performance evaluation comprising:

• Scientific validity — the association of the analyte with the clinical condition or physiological state, supported by scientific literature.
• Analytical performance — the device's ability to correctly detect or measure the analyte (sensitivity, specificity, precision, accuracy, limits of detection).
• Clinical performance — the device's ability to yield results that correlate with the intended clinical condition or physiological state. For Class C and D devices, performance studies are typically required.

The Performance Evaluation Report (PER) is part of the technical documentation and is updated throughout the device's lifecycle. The Periodic Safety Update Report (PSUR) is required for Class C and D devices (Article 81).

Conformity assessment procedures

Article 48 and Annexes IX, X, XI:

• Class A (non-sterile) — Annex II + Annex III; manufacturer self-declares.
• Class A sterile — as Class A, plus Notified Body assessment of sterility under Annex IX or XI.
• Class B — Annex IX (QMS + assessment of technical documentation on a representative basis), or Annex XI (production QA).
• Class C — Annex IX (full QMS + assessment of technical documentation), or Annex X (type-examination) + Annex XI (production QA).
• Class D — Annex IX with assessment of technical documentation for each device or device family, plus EU Reference Laboratory testing for performance and verification of common specifications.

Technical documentation

Annexes II and III of the IVDR set the contents — analogous to MDR but adapted for IVDs. Annex II covers the device description, design and manufacturing information, GSPR mapping, benefit-risk analysis, performance evaluation, and information supplied with the device. Annex III covers post-market surveillance including PMS plan, PSUR, and trend reporting. Retention period is 10 years from the last unit placed on the market (Article 10(7)).

EU Declaration of Conformity and CE marking

Article 17 and Annex IV set the Declaration's contents — including the Basic UDI-DI, Notified Body certificate references, and Single Registration Number. Article 18 requires the CE marking; the four-digit Notified Body identification number appears next to the mark for all classes except Class A non-sterile.

UDI and EUDAMED

The UDI system mirrors the MDR (Articles 24–28). EUDAMED's UDI/Device registration module operates for IVDs alongside medical devices; IVDs are registered in EUDAMED with their classification, Basic UDI-DI, and certificate information.

In-house IVDs (Article 5(5))

Article 5(5) provides an exemption for IVDs manufactured and used only within health institutions, subject to strict conditions: the institution must have a quality management system, justify that target patient needs cannot be met at the appropriate level of performance by an equivalent CE-marked device on the market, draw up documentation on manufacturing and performance, and report serious incidents. The conditions in Article 5(5)(c)–(i) became applicable on 26 May 2024.

Recent and upcoming changes

• Regulation (EU) 2022/112 — first extension of transitional periods.
• Regulation (EU) 2024/1860 (9 July 2024) — second extension; mandatory EUDAMED rollout module by module; cessation-of-supply notification duties.
• Common specifications under Article 9 — adopted for Class D devices by Commission Implementing Regulation (EU) 2022/1107.
• EU Reference Laboratories designated for Class D device testing — designation completed in 2024.
• The Commission has indicated targeted IVDR reform may be proposed in 2026 to address innovation and SME concerns.

Related legislation

• Medical Devices Regulation 2017/745 — companion regulation for medical devices.
• Regulation (EU) 2024/1860 — joint amendment of MDR and IVDR.
• General Product Safety Regulation 2023/988 — does not apply to IVDs covered by the IVDR.
• Directive 2001/83/EC on medicinal products — for companion diagnostics linked to specific medicines.

Common errors

• Continuing to place IVDD-certified devices on the market without meeting the conditions in Article 110. Conditions include no significant change of design or intended purpose and compliance with IVDR post-market surveillance provisions from 26 May 2022.
• Misclassification under Annex VIII. Many devices have moved from self-declared status under the IVDD to Class B, C, or D under the IVDR. Classification using IVDD rules is not sufficient.
• Missing Notified Body engagement. Class B, C, and D devices require Notified Body involvement; the manufacturer must engage a Notified Body designated under the IVDR (listed in NANDO).
• Inadequate performance evaluation. The IVDR's three-part performance evaluation (scientific validity, analytical performance, clinical performance) goes substantially beyond IVDD requirements.
• Missing PRRC. Article 15 requires a Person Responsible for Regulatory Compliance equivalent to the MDR's.

Sources

• Regulation (EU) 2017/746 (IVDR) — EUR-Lex consolidated text.
• Regulation (EU) 2024/1860 (transitional extension) — EUR-Lex.
• European Commission — Medical devices sector — new Regulations.
• Medical Device Coordination Group (MDCG) — Guidance documents.
• Commission Implementing Regulation (EU) 2022/1107 (common specifications, Class D) — EUR-Lex.