The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 is the legislation governing in vitro diagnostic medical devices placed on the European market. It replaced the previous In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC.
IVDR fundamentally changes IVD classification from the old self-certification model (where ~80% of IVDs were self-declared) to a risk-based system requiring Notified Body involvement for most device classes. This shift means that approximately 80% of IVDs now require Notified Body assessment — up from ~20% under the old directive.
Classification under IVDR follows Annex VIII, using 7 rules that assign devices to Classes A through D based on the intended purpose, risk to the individual patient, and risk to public health. Class D represents the highest risk (e.g., blood-borne disease screening), while Class A represents the lowest.
Scope & Applicability
→Applies to all in vitro diagnostic medical devices and accessories placed on the EU/EEA market
→Covers reagents, calibrators, control materials, specimen receptacles, and instruments for IVD examination
→Applies to companion diagnostics (CDx) for targeted therapies
→Does not cover general laboratory equipment without a specific IVD purpose
→Does not cover products for research use only (RUO) — unless they are marketed with an IVD intended purpose
Classification Classes
A
A
Lowest risk. General laboratory instruments and ancillary reagents with no specific diagnostic purpose. Self-declaration by the manufacturer, no Notified Body required unless the device is supplied sterile.
Examples
• Specimen containers
• Buffer solutions
• General-purpose culture media
• Laboratory pipettes
• Wash solutions
Requirements
✓Declaration of Conformity (self-certification)
✓Technical documentation per Annex II & III
✓Quality Management System
✓No Notified Body unless supplied sterile
✓EUDAMED registration
B
B
Low-to-medium risk. IVDs with a defined diagnostic purpose but where incorrect results do not directly endanger the patient. Requires Notified Body assessment of the QMS.
Medium-high risk. Includes self-tests, blood group testing, devices decisive for patient management, and companion diagnostics. Full Notified Body assessment including technical documentation review.
Examples
• Blood glucose self-test meters
• ABO/Rhesus blood group typing
• Tumour markers (PSA, CA-125)
• HbA1c tests
• Companion diagnostics (CDx)
• Drug monitoring for narrow therapeutic index drugs
Requirements
✓Full Notified Body assessment (Annex IX or X+XI)
✓Performance evaluation per Annex XIII
✓Annual PSUR
✓EUDAMED Summary of Safety and Performance
✓Clinical evidence requirements
D
D
Highest risk. Screening for life-threatening transmissible diseases where an incorrect result could cause death or severe disability. Most stringent assessment includes EU reference laboratory batch release verification.
Examples
• HIV screening tests
• Hepatitis B/C screening
• Blood bank screening for transmissible agents
• SARS-CoV-2 screening tests
• HTLV-I/II tests
Requirements
✓Annex IX QMS + batch release (Annex XI §9)
✓EU reference laboratory testing for each batch
✓Notified Body and Competent Authority involvement
✓Annual PSUR mandatory
✓Strictest post-market obligations
Key Rules & Concepts
Classification Rules (Annex VIII)
→Rule 1 — Devices for life-threatening transmissible diseases (blood-borne or sexually transmitted with high epidemic potential) → Class D
→Rule 2 — Devices for blood grouping or tissue typing for transfusion/transplantation safety → Class C (some D)
→Rule 3 — Devices intended for: (a) self-testing → Class C; (b) near-patient testing → Class C; (c) companion diagnostics → Class C
→Rule 4 — Devices for screening/diagnosis/staging of cancer → Class C
→Rule 5 — Devices for genetic testing → Class C
→Rule 6 — Other IVDs not covered by rules 1–5 and with a specific intended purpose → Class B
→Rule 7 — IVDs without a specific medical purpose (general lab instruments, buffers) → Class A
Key Differences from IVDD
→Risk-based classification replaces the old list-based system (Annex II List A/B)
→~80% of IVDs now require Notified Body involvement (vs ~20% under IVDD)