IVDR Class D Devices
IVDR Class D is the highest risk class for in vitro diagnostic devices. It covers tests that protect the safety of blood, tissues and organs, detect life-threatening agents with a high risk of spread, and determine key blood groups. Class D devices go through the most demanding conformity assessment in the IVDR: full notified body review of every device, common specifications, EU reference laboratory testing, possible expert panel consultation and batch verification. This guide explains each step and how I3CGlobal supports Class D manufacturers.
What is an IVDR Class D Device?
IVDR Class D devices present a high risk to the individual and a high risk to public health. An incorrect result could allow an infected blood donation to be transfused, a transmissible disease to spread, or a transfusion reaction to occur. Two Annex VIII rules lead to Class D:
- Rule 1: devices to detect a transmissible agent in blood, blood components, cells, tissues or organs to assess their suitability for transfusion, transplantation or cell administration, and devices to detect a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation. This includes devices used to determine the infectious load of such a disease when monitoring is critical.
- Rule 2: blood grouping and tissue typing devices for the ABO system, Rhesus system (RH1 to RH5), Kell (Kel1), Kidd (JK1, JK2) and Duffy (FY1, FY2), and irregular anti-erythrocytic antibodies.
Not every infectious disease test is Class D. Many are Class C under Rule 3. Check all rules on our IVDR classification guide.
Watch: IVDR Class D CE certification explained
Typical IVDR Class D Devices
These products are commonly placed in IVDR Class D. The final class depends on the intended purpose in the labelling and instructions for use.
Blood screening assays
HIV, HBV, HCV, HTLV and syphilis tests used to screen donated blood, tissues and organs (Rule 1).
Life-threatening agents
Tests for agents such as Ebola, variant CJD or other high-propagation pathogens (Rule 1).
Viral load monitoring
HIV or HBV viral load assays where monitoring is critical to patient management (Rule 1).
ABO & Rhesus reagents
Blood grouping reagents for ABO and RH1 to RH5 used before transfusion (Rule 2).
Kell, Kidd & Duffy typing
Antisera and assays for Kel1, JK1, JK2, FY1 and FY2 (Rule 2).
Antibody screening
Tests detecting irregular anti-erythrocytic antibodies before transfusion (Rule 2).
Key Requirements for IVDR Class D Certification
Class D manufacturers must meet every core IVDR obligation, with the deepest evidence and the most external scrutiny of any class.
Common specifications
Compliance with Regulation (EU) 2022/1107 common specifications for Class D devices, which set performance criteria and test panels for many blood screening and blood grouping assays.
Performance evaluation
Scientific validity, analytical and clinical performance in a PER updated at least annually, usually including clinical performance studies.
Technical documentation (Annex II & III)
A complete file for every device, including design, manufacturing, GSPR evidence, risk management and verification and validation. See IVDR technical documentation.
Quality management system
An EN ISO 13485 QMS aligned with the IVDR, with strong batch release, traceability and supplier controls, and a PRRC.
SSP, PSUR & PMPF
A summary of safety and performance (Article 29), an annual PSUR (Article 81) and a PMPF plan and report, all reviewed by the notified body.
Labelling, UDI & EUDAMED
IVDR-compliant labels and IFU, UDI carriers on labels and registration of devices and certificates in EUDAMED.
IVDR Class D Conformity Assessment Route
Class D manufacturers follow Annex IX (QMS and full technical documentation assessment for each device) or Annex X type examination with Annex XI production quality assurance. On top of the notified body review, Class D adds three external checks:
- EU reference laboratory (EURL) verification: where an EURL is designated for the device category, the notified body asks it to verify the claimed performance and compliance with the common specifications by laboratory testing (Article 48(3), Annex IX Section 4.9).
- Expert panel consultation: where no common specifications exist and it is the first certification for that type of device, the notified body must also ask an expert panel to review the performance evaluation report (Article 48(6)).
- Companion diagnostics: if the Class D device is also a companion diagnostic, the EMA or a national competent authority is consulted.
The notified body must take the EURL and expert panel opinions into account before issuing the certificate, so their timelines add to the project plan.
Batch verification of Class D devices
After certification, the manufacturer sends the test reports for each manufactured batch to the notified body (Annex IX Section 4.12). Where an EURL is designated, samples of each batch are also sent to the EURL for testing. Unless the notified body raises a concern within the set period, generally 30 days, the batch can be released to the market. Build this into your release process and stock planning.
Ongoing Requirements for IVDR Class D Manufacturers
| Document | Legal basis | Update frequency and review |
|---|---|---|
| Performance evaluation report | Article 56, Annex XIII Part A | At least annually; reviewed by the NB with the PSUR or significant changes |
| PMPF evaluation report | Article 56, Annex XIII Part B | As per the PMS and PMPF plans; reviewed with the PSUR |
| Periodic safety update report (PSUR) | Article 81 | At least annually; uploaded via EUDAMED for NB review |
| Summary of safety and performance (SSP) | Article 29 | Updated as soon as possible after significant change |
| Batch release reports | Annex IX Section 4.12 | Every batch, with EURL testing where designated |
IVDR Class D Transition Deadlines
Regulation (EU) 2024/1860 gave legacy Class D devices the shortest extension of any class. They may remain on the market only if they had a valid IVDD certificate or declaration before 26 May 2022, have no significant changes, and met these milestones:
| Milestone | Deadline | Status |
|---|---|---|
| QMS aligned with the IVDR | 26 May 2025 | Passed |
| Formal application lodged with a notified body | 26 May 2025 | Passed |
| Written agreement signed with the notified body | 26 September 2025 | Passed |
| End of transition for Class D legacy devices | 31 December 2027 | Upcoming |
IVDR Class D Compared with Class C
| Class C | Class D | |
|---|---|---|
| Risk | High individual, moderate public | High individual, high public |
| Technical documentation review | Per generic device group | Every device |
| Common specifications | Only where adopted | Yes, Regulation (EU) 2022/1107 |
| EURL testing and batch verification | No | Yes, where an EURL is designated |
| Expert panel | No | Yes, first-of-type devices without common specifications |
| Legacy device deadline | 31 December 2028 | 31 December 2027 |
Do you need an email containing full details about IVDR Class D within 2 minutes? Share your email below. Privacy Policy
One Partner for Everything IVDR Class D
Regulatory guidance and product technical support combined. We prepare your documentation, coordinate with the notified body, EURL and expert panel, and stay with you after the CE mark.
- Classification and common specifications gap assessment
- Performance evaluation, clinical performance studies and SSP
- QMS, batch release and PSUR processes
- Notified body, EURL and expert panel query support
Plan your Class D certification
Share your device details and get a tailored proposal. See typical IVDR certification costs.
IVDR Class D: Frequently Asked Questions
What additional requirements apply to Class D compared with other classes?
Full notified body review of every device, compliance with common specifications, EURL performance verification and batch testing where designated, possible expert panel consultation, and annual PSUR and PER updates.
What is the expert panel consultation under Article 48(6)?
For a Class D device with no common specifications that is the first of its type to be certified, the notified body must ask an expert panel for its views on the manufacturer’s performance evaluation report before issuing the certificate.
What role do EU reference laboratories play?
Where an EURL is designated for the device category, it verifies the device’s claimed performance and compliance with common specifications by laboratory testing, and tests samples of manufactured batches.
When is EMA or competent authority consultation needed?
When a Class D device is also a companion diagnostic, the notified body must consult the EMA or a national competent authority on its suitability for the medicinal product.
How long can legacy Class D devices stay on the market?
Until 31 December 2027, if all conditions of Regulation (EU) 2024/1860 were met, including a notified body application by 26 May 2025 and a written agreement by 26 September 2025.
Can I3CGlobal support Class D IVDR certification?
Yes. We provide regulatory and product technical consultation for Class D, from performance evaluation and technical documentation to notified body submission and coordination.
Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Swathi Tummala, Senior Regulatory Consultant, I3CGLOBAL