Q.01

What is an in vitro diagnostic medical device?

In EU law, an in vitro diagnostic medical device (IVD) is a medical device used outside the body ("in vitro") to examine specimens taken from the human body, such as blood or tissue donations. Its main purpose must be to give information about the person's health. The definition is in Article 2(2) of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) [1].

The legal definition (IVDR Article 2(2))

An IVD is "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, solely or principally for the purpose of providing information on one or more of the following":

  • (a) a physiological or pathological process or state;
  • (b) congenital physical or mental impairments;
  • (c) the predisposition to a medical condition or a disease;
  • (d) determining safety and compatibility with potential recipients;
  • (e) predicting treatment response or reactions;
  • (f) defining or monitoring therapeutic measures.

The same point adds: "Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices" [1].

What decides whether a product is an IVD

  • It must be a medical device first. IVDR Article 2(1) takes the meaning of "medical device" from Article 2(1) of the Medical Devices Regulation (MDR, Regulation (EU) 2017/745) [1]. That definition lists "providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations" as one of the specific medical purposes [2].
  • What the manufacturer says the product is for counts. The definition turns on use "intended by the manufacturer." Intended purpose is defined from the label, the instructions for use, promotional or sales materials or statements, or what the manufacturer specifies in the performance evaluation (Article 2(12)) [1].
  • Research-only products are not devices for performance study. Article 2(45) says a device intended for research purposes, "without any medical objective, shall not be deemed to be a device for performance study" [1].

Related IVDR definitions (Article 2) [1]

  • Specimen receptacle (point 3): a device, whether vacuum-type or not, specifically intended for the primary containment and preservation of human specimens for in vitro diagnostic examination.
  • Accessory (point 4): an article that is not itself an IVD but is intended to be used with one or more particular IVDs so they can be used as intended, or to directly assist their medical function.
  • Device for self-testing (point 5): a device intended to be used by lay persons. This includes testing services offered to lay persons through information society services.
  • Device for near-patient testing (point 6): a device not intended for self-testing that is used outside a laboratory, generally near or at the side of the patient, by a health professional.
  • Companion diagnostic (point 7): a device that is essential for the safe and effective use of a corresponding medicinal product. It identifies patients most likely to benefit from the product, or patients at increased risk of serious adverse reactions to it.
  • Kit (point 11): a set of components packaged together and intended to be used to perform a specific in vitro diagnostic examination, or part of one.
  • Calibrator (point 55): a measurement reference material used to calibrate a device.
  • Control material (point 56): a substance, material or article intended to be used to verify a device's performance characteristics.

Approach: I read the current consolidated texts of the IVDR (version of 10 January 2025) and the MDR (version of 19 July 2026). This answer gives the EU definition only; I did not compare it with how other jurisdictions, such as the US FDA, India's Medical Devices Rules 2017 or Swiss law, define an IVD.

Q.02

What does for in vitro diagnostic use only mean?

"For in vitro diagnostic use" is the label statement that tells users the product is a regulated in vitro diagnostic device. It means the product is meant for testing specimens taken from the human body, outside the body, to give medical information. It is not meant for use on or in a patient, and it is not a research-only product. Neither the EU nor the US rule uses the word "only": the EU requires "an indication" that the device is an IVD, and the US requires the exact words "For In Vitro Diagnostic Use". The statement reflects the product's legal status but does not create it. EU guidance says a product does not become an IVD just because its label carries the phrase.

EU (IVDR, Regulation (EU) 2017/746)

  • Label: Annex I, Section 20.2(e) says the label "shall bear… an indication that the device is an in vitro diagnostic medical device, or if the device is a 'device for performance study', an indication of that fact." [3]
  • Instructions for use: Section 20.4.1(d) requires the same indication there too [3].
  • What the statement can't do: MDCG 2024-11 says "products cannot be brought into the scope of the IVDR merely by mentioning IVD or 'for in vitro diagnostic use'" [4]. For general laboratory products it adds: "Merely adding the statement 'for in vitro diagnostic use' to a product is not sufficient to qualify a product as an IVD." Such a product becomes an IVD only if its characteristics make it specifically intended for in vitro diagnostic examination [5]. Whether something is an IVD depends on the manufacturer's intended medical purpose under Article 2(2), not on the wording of the label.
  • Contrast with "research use only" (RUO): The IVDR does not apply to "products for general laboratory use or research-use only products", unless they are specifically intended by their manufacturer to be used for in vitro diagnostic examination (Article 1(3)(a)) [6]. RUO products "cannot be intended by their manufacturers for a medical purpose" [7]. If a clinical trial protocol gives an RUO assay a medical purpose, the assay "becomes an IVD and can no longer be considered a research use only assay" [8].

US (FDA, 21 CFR 809.10)

  • Label: Under § 809.10(a)(4), the label "shall state" a statement "For In Vitro Diagnostic Use" and "any other limiting statements appropriate to the intended use of the product." For prescription IVDs, that limiting statement must be "Rx only" (or "℞ only") or the "Caution: Federal law restricts this device to sale by or on the order of a ___" wording.
  • Products that carry different statements: Under § 809.10(c)(2), products shipped for investigations not subject to Part 812 carry a different statement on all labeling:
    • Research-phase products not represented as effective IVDs: "For Research Use Only. Not for use in diagnostic procedures."
    • Products shipped for testing before full commercial marketing: "For Investigational Use Only. The performance characteristics of this product have not been established."

In practice: the statement separates a finished IVD from three other kinds of product:

  • research-only products (outside the IVDR; under the US "For Research Use Only" statement);
  • devices still under evaluation (in the EU a "device for performance study"; in the US "For Investigational Use Only");
  • general laboratory products.

Approach: I read the current consolidated IVDR (Annex I and Article 1) and MDCG guidance 2022-10 and 2024-11. The FDA rule is not in the datasets I can search, so I took it from 21 CFR 809.10 on the official eCFR.

Q.03

How are these devices classified in India?

India's Medical Devices Rules, 2017 put IVDs into four risk classes: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). Rule 4(2) says IVDs "shall be classified" on the basis of the parameters in Part II of the First Schedule. Ordinary medical devices are classified separately, under Part I [9]. The Central Licensing Authority assigns the class based on intended use. CDSCO publishes the class for each device type on its website, and the Authority "may" add to or remove from that list, or change a device's class [9].

Basic principles (First Schedule, Part II, paragraph 1)

  • Classification follows the device's intended purpose [10].
  • Devices used together are each classified separately. Accessories are classified "in their own right" [10].
  • Software that drives or influences a device falls into the same class as the device. Standalone software that controls or influences the output of a separate IVD takes that IVD's class. Calibrators "should be treated" in the same class as the reagent they are used with [11].
  • If more than one rule applies, the stricter rule that gives the higher class "shall apply" [11].

Classification rules (paragraph 2)

RuleClass DClass CClass B / A
(i) Transmissible agentsDetects a transmissible agent in blood, blood components, cells, tissue or organs to assess whether they are suitable for transfusion or transplant; or detects an agent that causes a life-threatening disease with a high risk of spreadingSexually transmitted agents; infectious agents in CSF or blood with a risk of limited spread; infections where a wrong result could cause death or severe disability; prenatal immune status (e.g. Rubella, Toxoplasmosis); companion-type uses (selecting patients for therapy, cancer diagnosis); human genetic testing; monitoring where a wrong result risks an immediately life-threatening decision (cardiac markers, cyclosporin, prothrombin time); HIV/HCV viral load or genotyping; fetal congenital disorder screeningn/a
(ii) Blood grouping / tissue typingABO, rhesus, Kell, Kidd, Duffy systems (e.g. HLA, Anti-Duffy, Anti-Kidd)Other blood grouping or tissue typing for transfusion or transplant compatibilityn/a
(iii) Self-testingn/aSelf-tests by defaultClass B if the results are not for a medically critical status, or are preliminary results that need laboratory confirmation
(iv) Near-patient testingn/aBlood gas analysis or blood glucose determinationn/a
(v) IVD proceduresn/an/aClass A: reagents or articles with specific characteristics for an IVD procedure, IVD instruments, specimen receptacles
(vi) Othern/an/aClass B: anything not covered by (i) to (v)

Sources for the table: [11][12]

How CDSCO's published IVD list applies the rules (examples)

  • HIV test reagents/kits for detecting HIV in blood or body fluids: Class D [13]
  • HIV viral load test reagents/kits: Class C [14]
  • Glucose test reagents/kits, both laboratory use and preliminary self-testing: Class B [15][16]
  • Urine analyte strips for preliminary estimation: Class B [17]
  • Blood collection tubes, microcuvettes, ABG samplers and other specimen receptacles: Class A [18][19][20][21]

What the class changes in practice (CDSCO IVD FAQ)

  • Site audit: a domestic Class A IVD needs no audit of the manufacturing site before licensing. Class B, C and D sites are audited or inspected before the manufacturing licence is granted [22].
  • If CDSCO changes a product's class: the existing licence stays valid until the authority decides on the application. Only additional documents are needed, plus fees when the move is from A to C/D or from B to C/D [22].
  • Performance evaluation: an application for a Class B, C or D IVD must include a performance evaluation report from the central medical device testing laboratory or a registered testing laboratory [23].

Approach: I read Rule 4 and the First Schedule, Part II of India's Medical Devices Rules, 2017, the CDSCO IVD FAQs, and the CDSCO risk-classification list for IVDs. The Rules text I had is the original 2017 Gazette version, not a consolidation of later amendments, so changes made to the First Schedule after 2017 are not reflected here.

Q.04