Before any classification or conformity assessment, a company must answer a basic question: is my product an in vitro diagnostic medical device under Regulation (EU) 2017/746? The answer depends on the intended purpose the manufacturer assigns to it.
What counts as an IVD
An IVD is any reagent, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended by the manufacturer to be used in vitro to examine specimens derived from the human body, solely or principally to provide information about:
- a physiological or pathological process or state
- congenital physical or mental impairments
- the predisposition to a medical condition or disease
- safety and compatibility with potential recipients
- the likely response or reaction to treatment
- the definition or monitoring of therapeutic measures
Specimen receptacles are also IVDs. Accessories that enable an IVD to be used as intended are regulated in their own right.
Software
Standalone software can be an IVD when it processes data from in vitro examinations to provide information for diagnostic or therapeutic purposes. Bioinformatics pipelines and variant interpretation tools used in clinical genetic testing are typical examples. The intended purpose, labeling and marketing claims decide: a tool marketed for research only is not an IVD, while the same tool marketed for clinical reporting is. Guidance document MDCG 2019-11 explains how to qualify and classify software.
Companion diagnostics
A companion diagnostic is essential for the safe and effective use of a corresponding medicine, for example to identify patients most likely to benefit. Companion diagnostics are Class C, and their notified body assessment includes consultation with the medicines regulator.
What is not an IVD
- Research Use Only (RUO) products without a medical purpose; labeling them RUO while promoting clinical use is a common compliance risk
- General laboratory products, unless specifically intended by the manufacturer for IVD examinations
- Products for forensic, paternity or purely lifestyle purposes without a medical intended purpose
- Invasive sampling devices and devices applied directly to the body to obtain specimens, which fall under the MDR
In-house devices and laboratory-developed tests
Health institutions in the EU may make and use their own tests without CE marking under Article 5(5), as long as they meet the general safety and performance requirements and do not transfer the devices to another legal entity. Additional conditions have been phased in, including an appropriate quality management system and EN ISO 15189 compliance (from May 26, 2024). The requirement to justify that patient needs cannot be met by an equivalent device on the market applies from December 31, 2030.
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.