🏥 Key Takeaways for Healthcare Workers
The essential points — read this first if you're short on time
IVDs (lab tests, reagents, analysers) are now regulated by the IVDR, not the old IVDD
New risk classes A→D replace the old list system — most IVDs now need independent oversight
Blood screening tests (HIV, Hep B/C) are Class D — the highest risk, verified by EU Reference Labs
Companion diagnostics (e.g., HER2 test before Herceptin) are Class C — essential for safe prescribing
Home glucose monitors are Class C — incorrect results could affect insulin dosing
Some IVDs may be discontinued during transition — check with procurement for critical tests
Report IVD incidents (wrong results, malfunctions) just like you would for medical devices
Staggered deadlines: Class D by May 2025, Class C by 2026, Class B/A by 2027
IVDR Essentials — In Vitro Diagnostic Regulation
The In Vitro Diagnostic Regulation (EU) 2017/746 replaced the old IVDD and fundamentally changed how lab tests, reagents, and diagnostic instruments are classified, assessed, and monitored across the EU.
80%
of IVDs now need Notified Body assessment (up from 20%)
4
risk classes: A (lowest) → D (highest)
7
classification rules in Annex VIII
2027
final transition deadline for all classes
📌 Select your perspective to see tailored tips throughout:
🔄 From IVDD to IVDR — What Changed?
The previous IVDD (98/79/EC) used a list-based system where ~80% of IVDs were self-certified. The IVDR introduces a risk-based approach that dramatically increases oversight.
❌ Old System (IVDD)
- • List-based classification (Annex II Lists A & B)
- • Only ~20% of IVDs needed Notified Body
- • Minimal performance evaluation requirements
- • Limited post-market surveillance
- • No central database, no UDI
- • Clinical evidence often literature-only
✅ New System (IVDR)
- • Risk-based rules — 7 rules, 4 classes (A–D)
- • ~80% of IVDs now need Notified Body
- • Rigorous 3-pillar performance evaluation
- • Full PMS system with PMPF
- • EUDAMED mandatory + UDI required
- • Performance studies may be required
💡 Key Impact
Under the IVDD, only ~8% of IVDs were in higher-risk categories. Under the IVDR, that rises to ~80%. This has created significant Notified Body capacity challenges and is the main reason for extended transition periods.
📊 IVDR Classification System (Annex VIII)
Four risk classes based on 7 classification rules. Tap any class for details.
🏥 Why This Matters to You
Understanding IVD classification helps you appreciate the level of scrutiny behind the tests you rely on daily. Higher-class IVDs (C & D) have undergone more rigorous independent assessment. If you notice performance issues, the class influences how urgently the manufacturer and HPRA need to respond.
Your hospital lab receives a new batch of wash buffer solutions used to rinse slides during histology staining.
Under IVDR, what class is this product?
⚖️ The Seven Classification Rules (Annex VIII)
Classification is based on intended purpose. When multiple rules apply, the highest class takes precedence.
🎯 Special IVD Categories
💊 Companion Diagnostics (Article 2(7))
A companion diagnostic is an IVD essential for the safe and effective use of a corresponding medicinal product — it identifies patients who will benefit from a therapy, or those at risk of serious adverse reactions.
HER2 testing
Drug: Trastuzumab (Herceptin®)
🎗️ Breast cancer
EGFR mutation
Drug: Gefitinib (Iressa®)
🫁 NSCLC lung cancer
BRAF V600E
Drug: Vemurafenib (Zelboraf®)
🔬 Melanoma
PD-L1 expression
Drug: Pembrolizumab (Keytruda®)
🎗️ Various cancers
KRAS mutation
Drug: Cetuximab (Erbitux®)
🎗️ Colorectal cancer
ALK rearrangement
Drug: Crizotinib (Xalkori®)
🫁 Lung cancer
Key Rules for Companion Diagnostics
- Classified as Class C under Rule 5(b)
- Must be referenced in the medicinal product's SmPC
- Notified Body must consult a medicines authority (Article 48(3))
🏥 For Prescribers: Always confirm the companion diagnostic used is the one validated and referenced in the medicinal product's SmPC. Using an unvalidated assay may lead to incorrect treatment decisions.
An oncologist wants to prescribe pembrolizumab (Keytruda®) for a lung cancer patient. Before prescribing, they need a PD-L1 expression test.
Under IVDR, what type of IVD is this PD-L1 test and what class is it?
🏠 Self-Testing IVDs (Rule 6)
A self-testing device is an IVD intended for use by lay persons (non-professionals) in a home environment (Article 2(4)). These receive special classification treatment.
⬆️ General Rule: Class C Minimum
- • Blood glucose self-monitors
- • INR/coagulation self-testing
- • Coeliac disease self-tests
- • COVID-19 self-tests (antigen)
- • Allergy self-tests (specific IgE)
⬇️ Class B Exceptions
- • Pregnancy tests (hCG detection)
- • Ovulation/fertility tests (LH detection)
- • Cholesterol tests (capillary blood)
Only if manufacturer demonstrates adequate performance in lay-user hands
📋 Enhanced Requirements (Annex I, §20.4.2)
Self-testing IVDs must have: clear instructions for lay persons, design to minimise errors, interpretation aids, and warnings about limitations.
A pharmacy stocks home pregnancy tests (hCG detection) alongside blood glucose self-monitoring kits. A customer asks if they are regulated the same way.
Are these two self-testing IVDs in the same IVDR class?
🏨 Near-Patient Testing / Point-of-Care (Rule 7)
Near-patient testing (POCT) means IVDs used near the patient, outside a lab, by healthcare professionals (not lay persons). Under Rule 7, these are Class B minimum.
🏥 For Hospital Settings: POCT devices still need quality management (EQA, IQC, competency checks). Results should be validated against reference lab methods.
🛡️ EU Reference Laboratories (Article 100)
A unique IVDR feature: independent EU-designated labs that verify performance of Class D devices.
Batch testing to verify manufacturer performance claims
Scientific advice to Notified Bodies & authorities
Provide reference materials, methods & panels
Participate in inter-laboratory comparison exercises
🔬 Performance Evaluation (Article 56 & Annex XIII)
The IVDR equivalent of the MDR's clinical evaluation. Establishes scientific validity, analytical performance, and clinical performance of an IVD.
Scientific Validity
Is the analyte actually relevant to the clinical condition?
Analytical Performance
Can the device accurately detect/measure the analyte?
Clinical Performance
Does it give clinically useful results in real patients?
🏥 What This Means for Your Laboratory
When evaluating new IVDs for procurement, ask the manufacturer for their performance evaluation summary — particularly the clinical performance data showing how the test performs in your target population.
A manufacturer submits documentation for a new cardiac troponin point-of-care test. The Notified Body asks for the "three pillars" of evidence.
What are the three pillars of IVDR performance evaluation?
📅 IVDR Transition Timeline
The IVDR became applicable 26 May 2022. Staggered grace periods allow legacy devices to transition based on class.
IVDR Applied
Fully applicable. All new IVDs must comply. Grace periods begin.
Class D Deadline
Legacy Class D devices must have IVDR certificates. EU Reference Lab verification required.
Class C Deadline
Legacy Class C devices (self-testing, companion diagnostics) must transition.
Class B & A Deadline
All remaining legacy IVDs must have IVDR certificates. Final end of all grace periods.
Sell-off Ends
Devices placed on market during grace period may be available until this date (Art. 110(4a)).
🏥 Impact on Your IVD Supply
Some IVDs may be discontinued if manufacturers decide IVDR certification isn't justified. Work with procurement to identify critical IVDs and confirm manufacturers plan to certify. Have contingency plans.
✅ Module Summary
For Your Daily Practice
For Your Laboratory
Irish Context — IVD Regulation & the HPRA
The HPRA regulates IVDs in Ireland under IVDR (EU) 2017/746. Laboratories and hospitals using IVDs should verify that products carry the correct IVDR CE marking.
In-house manufactured IVDs (e.g., laboratory-developed tests) used within HSE facilities now fall under IVDR Article 5(5) and must meet specific requirements.
Useful HPRA Links:
This is educational content only and is not an accredited or externally verified course. Always refer to official HPRA publications and your facility's own policies.
Knowledge Check
8 questions · 80% required to pass
Q1.Scenario: Your hospital blood bank uses an ABO/Rh typing kit to verify blood group before every transfusion. Under the IVDR, what class is this IVD?
Q2.Scenario: An oncologist wants to prescribe trastuzumab (Herceptin®) for a breast cancer patient. The lab runs an HER2 expression test first. Under IVDR, what type of IVD is this?
Q3.Scenario: A pharmacy sells home pregnancy tests (hCG detection) and home blood glucose monitors side by side. A customer asks: "Are they regulated the same way?" What do you tell them?
Q4.Scenario: Under the old IVDD, your lab's clinical chemistry analysers (e.g., sodium, potassium, creatinine tests) were self-certified by the manufacturer. What changed under the IVDR?
Q5.Scenario: A manufacturer submits a new cardiac troponin rapid test for IVDR conformity assessment. The Notified Body asks for the "three pillars" of evidence. What are they?
Q6.Scenario: Your hospital lab discovers that a frequently-used IVD (Class C, IVDD-certified) does not yet have an IVDR certificate. The manufacturer says they applied to a Notified Body in 2023. Can you still use this device legally in 2026?
Q7.Scenario: A nurse uses a ward-based blood glucose analyser to test a patient's blood sugar at the bedside (not the patient testing themselves). Under IVDR, this near-patient/point-of-care device is classified as:
Q8.Scenario: A Class D IVD manufacturer (blood screening test) has obtained a positive opinion from their Notified Body. However, the Notified Body says an additional step is required before CE marking. What is this unique IVDR requirement?
0/8 answered
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