Glossary Updates12 new terms added to the glossaries · October 2, 2026, 22:44 CEST
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Glossary · EU medical devices: MDR

Medical device vs. IVD: MDR vs. IVDR

Also known as: MDR vs. IVDR, IVDR vs. MDR, Medical device vs. in vitro diagnostic

In EU law, medical devices fall under the Medical Device Regulation (EU) 2017/745 and in vitro diagnostic medical devices under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. An IVD is a device intended for the in vitro examination of specimens derived from the human body; all other medical devices are governed by the MDR.

  • EU
  • MDR
  • IVDR

In one sentence

MDR covers medical devices, IVDR covers in vitro diagnostics that examine specimens from the body. Classes, evidence and deadlines differ.

Example

A company makes a blood glucose meter with test strips and a separate reusable insulin pen: the meter and strips are IVDs under the IVDR (Annex VIII rules, classes A to D), the reusable pen is a medical device under the MDR (classes I to III).

How it applies

  • Dates: The MDR has applied since May 26, 2021; the IVDR since May 26, 2022. Both have separate transition periods.
  • Classification: MDR classes I (with Is, Im, Ir), IIa, IIb and III under 22 rules; IVDR classes A, B, C and D under 7 rules, both in Annex VIII. See MDR classification and IVDR classification.
  • Evidence: The MDR requires clinical evaluation and, after market entry, PMCF. The IVDR requires performance evaluation (scientific validity, analytical and clinical performance) and PMPF.
  • Public summaries: The MDR has the SSCP for implantable and class III devices; the IVDR has the summary of safety and performance (SSP) for class C and D devices.
  • Shared structure: Economic operators, PRRC, UDI, EUDAMED, technical documentation (Annexes II and III) and post-market surveillance follow the same pattern in both, often with shifted article numbers.
  • Technical documentation: Cite the correct regulation and article numbers; an article number from the MDR often points to a different topic in the IVDR, for example Article 32 MDR (SSCP) vs. Article 29 IVDR (SSP).

Medical device vs. IVD

An IVD is legally a kind of medical device, but it is regulated by its own regulation. The test is what the product examines: specimens outside the body (blood, tissue, urine) make it an IVD; acting on or in the body makes it an MDR device. Software that analyzes IVD results for a medical purpose may itself be an IVD; see medical device software.