The IVDR introduced a risk-based classification system with four classes, from Class A (lowest risk) to Class D (highest risk). Classification determines whether a notified body is involved and how deep its review goes. Under the old directive, most IVDs were self-certified; under the IVDR, the large majority need a notified body.
The four classes
| Class | Risk | Examples | Notified body? |
|---|---|---|---|
| A | Low individual and public health risk | General laboratory reagents and buffers, IVD instruments, specimen receptacles | No (except sterile Class A) |
| B | Moderate individual and/or low public health risk | Pregnancy and fertility self-tests, cholesterol and glucose self-tests, most products not covered by other rules, controls without assigned values | Yes |
| C | High individual and/or moderate public health risk | Human genetic testing, cancer screening and diagnosis, companion diagnostics, sexually transmitted infections, most self-tests | Yes |
| D | High individual and high public health risk | Blood, tissue and organ donor screening for transmissible agents, life-threatening infections with high risk of spread, certain blood grouping | Yes, with the deepest review |
The seven classification rules (Annex VIII)
- Rule 1 (Class D): detecting transmissible agents in blood, cells, tissues or organs for transfusion or transplantation, and agents causing life-threatening diseases with a high risk of propagation
- Rule 2: blood grouping and tissue typing, Class C, with certain markers in Class D
- Rule 3 (Class C): including sexually transmitted agents, infectious agents where an error could cause death or severe disability, cancer screening, diagnosis and staging, human genetic testing, companion diagnostics, congenital disorder screening, and monitoring of medicines where an error could be life-threatening
- Rule 4: self-testing devices are Class C, except tests for pregnancy, fertility, cholesterol, glucose and certain urine markers, which are Class B; near-patient tests are classified in their own right
- Rule 5 (Class A): general laboratory products, instruments specifically intended for IVD procedures, and specimen receptacles
- Rule 6 (Class B): devices not covered by any other rule
- Rule 7 (Class B): controls without an assigned quantitative or qualitative value
Applying the rules
- Classification follows the intended purpose stated by the manufacturer
- If several rules apply, the highest class applies
- Software that drives or influences a device takes the class of that device; standalone software is classified in its own right
- Guidance document MDCG 2020-16 provides worked examples
What this means for genomics
Software and assays used for human genetic testing generally fall into Class C under Rule 3. That means a notified body will assess the quality system and the technical documentation, and the performance evaluation must cover scientific validity, analytical performance and clinical performance for the stated intended purpose.
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.