In Vitro Diagnostic Medical Devices Regulation (IVDR)
The EU regulation governing in vitro diagnostic medical devices, applying since 26 May 2022 in place of the IVD Directive (98/79/EC). The IVDR introduced risk-based classification into classes A–D, mandatory notified-body conformity assessment for most classes, performance evaluation built on scientific validity, analytical performance, and clinical performance, plus UDI and post-market performance follow-up. Transition periods for legacy devices were extended, most recently by Regulation (EU) 2024/1860.
What this does not cover
stated in the document's own scope- Covers in vitro diagnostic medical devices; general medical devices, including software that is not an IVD, fall under the MDR (2017/745).
- The Article 5(5) in-house exemption for health-institution tests is conditional and partial — it does not exempt laboratory-developed tests from the regulation generally.
- Regulates devices placed on the EU market; the accreditation of the medical laboratories that use them is the province of ISO 15189 and national schemes.
- Sets the EU regime; the US regulates IVDs through FDA device law, a separate system with different classification and review routes.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EU) 2017/746 — the In Vitro Diagnostic Medical Devices Regulation — governs IVDs on the EU market: reagents, calibrators, instruments, specimen receptacles, and software used for the in vitro examination of human specimens. Applying since 26 May 2022 in place of the IVD Directive (98/79/EC), it rebuilt the regime around risk: devices are classified A to D under rule-based classification, and every class except non-sterile class A requires notified-body conformity assessment — a step change from the Directive, under which most IVDs were self-declared. The regulation demands performance evaluation resting on three pillars — scientific validity, analytical performance, and clinical performance — plus UDI, EUDAMED registration, and post-market performance follow-up, with a limited in-house exemption for tests made and used within health institutions.
Scope & applicability
In vitro diagnostic medical devices placed on the EU market — reagents, instruments, specimen receptacles, and software for in vitro examination of specimens. General medical devices fall under the MDR (2017/745), a separate regulation.
Legal basis & how it acquires force
A regulation of the European Parliament and of the Council of 5 April 2017, directly applicable in all Member States without transposition, repealing Directive 98/79/EC. It applies since 26 May 2022, with conditional transition periods for legacy devices holding Directive-era certificates or declarations of conformity — most recently extended by Regulation (EU) 2024/1860 to 31 December 2027 for class D, 31 December 2028 for class C, and 31 December 2029 for class B and sterile class A devices.
Document structure
| Part | Covers |
|---|---|
| Scope, definitions and economic operators | The devices and accessories covered and the obligations of manufacturers, authorised representatives, importers, and distributors |
| Identification, traceability and EUDAMED | UDI assignment, device and operator registration, and the European database on medical devices |
| Classification and conformity assessment | The class A–D rule-based classification and the notified-body assessment routes per class |
| Performance evaluation and performance studies | Scientific validity, analytical performance, and clinical performance, and the conduct of performance studies |
| Post-market surveillance and vigilance | Post-market performance follow-up, periodic safety update reports, and incident reporting |
| Annexes | General safety and performance requirements, technical documentation, classification rules, conformity assessment procedures, and performance-evaluation requirements |
Key requirements
- Classification into classes A–D by risk rules, with notified-body involvement for all but non-sterile class A
- A quality management system and technical documentation per the general safety and performance requirements
- Performance evaluation demonstrating scientific validity, analytical performance, and clinical performance
- UDI assignment and registration, and EUDAMED registration obligations
- Post-market surveillance and post-market performance follow-up feeding periodic safety update reports for higher classes
Implementation tips
- Treat IVDR classification as the critical path — the jump from self-declaration under the IVD Directive to notified-body assessment is the transition's bottleneck, and the extended deadlines are conditional on legacy status and an eventual notified-body agreement
- In-house (laboratory-developed) tests get a limited exemption under Article 5(5) with its own conditions — it is not a general LDT carve-out
Revision notes
Applies since 26 May 2022. Regulation (EU) 2024/1860 extended the conditional transition periods for legacy devices: class D to 31 December 2027, class C to 31 December 2028, class B and sterile class A to 31 December 2029.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The IVDR is the diagnostics sibling of the Medical Device Regulation (2017/745): the two share the economic-operator model, UDI and EUDAMED infrastructure, notified-body machinery, and vigilance architecture, while diverging where diagnostics differ — classification rules, performance evaluation in place of clinical evaluation, and performance studies in place of clinical investigations. ISO 13485 remains the harmonised quality-system standard beneath it, ISO 20916 governs clinical performance studies, and the laboratory context it regulates borders ISO 15189 accreditation for medical laboratories.
Regulation (EU) 2017/746: frequently asked questions
Quick answers to common questions about Regulation (EU) 2017/746.
When did the IVDR start to apply, and what are the transition deadlines?
The IVDR applies since 26 May 2022. For legacy devices with Directive-era certificates or declarations of conformity, Regulation (EU) 2024/1860 extended the conditional transition periods: class D devices to 31 December 2027, class C to 31 December 2028, and class B and sterile class A to 31 December 2029, subject to conditions including an agreement with a notified body.
How does IVDR classification work?
Devices are classified A to D by rule-based classification reflecting patient and public-health risk — class D covering the highest-risk tests such as those for life-threatening transmissible agents. Every class except non-sterile class A requires notified-body conformity assessment, which reversed the Directive-era default of self-declaration.
What are the three pillars of IVDR performance evaluation?
Scientific validity (the association of the analyte with the clinical condition), analytical performance (the device's ability to correctly measure the analyte), and clinical performance (its ability to yield results correlated with the clinical condition in the intended population). All three must be demonstrated and kept current through post-market performance follow-up.
Does the IVDR allow laboratory-developed tests?
Within limits. Article 5(5) exempts tests manufactured and used within a single health institution from most requirements, but only under conditions — including an appropriate quality system, justification that the target patient group's needs cannot be met by an equivalent CE-marked device, and compliance with the general safety and performance requirements of Annex I. It is a conditional carve-out, not a general exemption.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.