MDCG 2024-11: Qualification of in vitro diagnostic medical devices, explained
How intended purpose and product characteristics determine whether a reagent, instrument, specimen container, kit, collection device or software is an IVD.
MDCG 2024-11 explains the boundary of the IVDR. An IVD must be intended to examine human-derived specimens in vitro for a medical information purpose. Specific intended purpose and characteristics—not a bare “for IVD use” label— separate IVDs and accessories from general laboratory equipment, RUO products and MDR collection devices.
Who this applies to
This guidance is for manufacturers deciding whether a product falls under the IVDR as an IVD or an IVD accessory. It covers reagents, instruments, specimen receptacles, collection products, kits, calibrators, controls and software, and it explains several boundaries with general laboratory products and MDR medical devices.
Qualification comes before classification. Only after the product is shown to be an IVD or accessory should you apply MDCG 2020-16 and Annex VIII.
The qualification test
An IVD is intended to be used in vitro to examine specimens derived from the human body and to provide information for one or more IVDR medical purposes. The manufacturer's intended purpose and the product's objective characteristics must support that conclusion.
Writing “for in vitro diagnostic use” on a general product does not pull it into the IVDR. Conversely, calling a product “research use only” does not keep it outside the IVDR if its real intended purpose and presentation are diagnostic.
Common boundary decisions
Product situation |
Usual qualification |
|---|---|
Container specifically intended for primary containment and preservation of a human specimen for IVD examination |
IVD specimen receptacle |
Needle, lancet, swab or other collection product directly applied to the body |
MDR medical device, not an IVD accessory |
General centrifuge, pipette, empty tube or instrument without an IVD-specific intended purpose or characteristics |
General laboratory product outside IVDR |
Instrument or reagent specifically intended for an identified IVD examination |
IVD or IVD accessory, depending on its role |
Cleaning solution specifically intended to enable a defined IVD analyser |
IVD accessory |
Product measuring directly on the body without examining a derived specimen |
MDR medical device, not an IVD |
“Primary” containment is about the receptacle's intended direct contact and preservation role, not necessarily which container happens to be used first in time.
Kits and combined products
An IVD kit is a set of components packaged together for a specific IVD examination or part of one. It may contain IVDs, accessories, a CE-marked MDR collection device and general products. The kit itself is CE marked and documented as an IVD.
A physically integral product containing an IVD part and an MDR medical-device part is governed by the MDR, with IVDR requirements applying to the IVD part. Products merely packaged together or referenced in instructions remain separately qualified. Medicinal products cannot simply be absorbed into an IVD kit.
Software can qualify without touching the specimen
Standalone software may be an IVD when its intended medical information is based on results from IVDs, even though the software does not directly examine the specimen. Define the input, processing, output and medical purpose. Software that only stores, transfers or displays data without an IVD medical function may fall outside that definition.
Calibrators, controls and research products
Calibrators and control materials can be IVDs when their intended purpose meets the definition. Internationally certified reference materials and materials used within external quality-assessment schemes are excluded in the circumstances described by the IVDR; supplying the same material separately as an IVD control can create a different role.
RUO products must not have a manufacturer-intended medical purpose. Marketing, instructions, sales channels and product characteristics should tell the same story.
What this means for you, practically
- Write the intended-purpose facts. State specimen, medical information, user, workflow, population and the role of the product in the examination.
- Assess each component separately. Qualify the collection device, receptacle, reagent, instrument, software and assembled kit before deciding the system route.
- Use characteristics, not disclaimers. Record why the product is specifically diagnostic or genuinely general-purpose/RUO.
- Resolve MDR/IVDR interfaces. Document direct body contact, physical integration and whether components are packaged or merely referenced together.
- Classify only after qualification. Apply MDCG 2020-16 to every qualified IVD and accessory in its own right.
Related MDCG guidance
Related resources
IVDR Requirements: What You Need To Become Compliant
Sebastian Skorka
MDCG guidance
MDCG 2023-7: Exemptions from clinical investigations
When Article 61(4)–(6) lets you rely on existing data instead of a new clinical investigation.
MDCG guidance
MDCG 2020-16: Classification rules for IVDs
How to classify an IVD under IVDR Annex VIII, including software, companion diagnostics and multi-purpose products.
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