IVDR Class C Devices
IVDR Class C covers in vitro diagnostic devices with high individual risk and moderate public health risk, where a wrong result could lead to a life-threatening situation or severely affect patient management. Cancer, genetic, infectious disease, companion diagnostics and most self-tests sit here. Every Class C device needs a notified body that audits the QMS and assesses the technical documentation of each generic device group. This guide explains the requirements, the route, the 2028 transition deadline and how I3CGlobal gets Class C devices certified.
Definition
What is an IVDR Class C Device?
IVDR Class C devices present a high risk to the individual and a moderate risk to public health. Three Annex VIII rules lead to Class C:
- Rule 3: detection of sexually transmitted agents, infectious agents in CSF or blood without a high risk of propagation, infection or immune status, cancer screening, diagnosis and staging, human genetic testing, companion diagnostics, monitoring of medicinal products, management of life-threatening diseases, congenital disorder screening in the embryo or foetus, and newborn screening.
- Rule 2: blood grouping and tissue typing for immunological compatibility, except the markers listed for Class D.
- Rule 4: devices for self-testing, except the pregnancy, fertility, cholesterol and urine test exceptions that are Class B.
If the device detects a transmissible agent in blood, tissues or organs for transfusion or transplantation, or a life-threatening agent with a high risk of propagation, it is Class D. Check all rules on our IVDR classification guide.
Watch: how to get CE marking for IVDR Class C devices
Typical IVDR Class C Devices
These products are commonly placed in IVDR Class C. The final class always depends on the intended purpose stated in the labelling and instructions for use.
Cancer markers
PSA, CA-125, CEA and other tests for cancer screening, diagnosis, staging or monitoring (Rule 3).
Human genetic testing
Germline mutation tests such as BRCA1/2, pharmacogenetic tests and hereditary disease panels (Rule 3).
Companion diagnostics
Tests that identify patients suitable for a specific medicinal product, for example HER2 or EGFR mutation assays (Rule 3).
Infectious disease tests
Chlamydia, gonorrhoea, HPV, SARS-CoV-2, influenza and immune status tests such as rubella or toxoplasma (Rule 3).
Self-tests
Blood glucose meters, coagulation self-tests and other home tests outside the Rule 4 exceptions.
Blood grouping & tissue typing
HLA typing and blood group markers not listed in Rule 2 for Class D (Rule 2).
Key Requirements for IVDR Class C Certification
Class C manufacturers must show compliance with Annex I GSPRs, run an IVDR-aligned EN ISO 13485 QMS and submit complete Annex II and III technical documentation with strong performance evidence.
01
Performance evaluation
Scientific validity, analytical performance (accuracy, precision, LoD, linearity, interference, cross-reactivity) and clinical performance (clinical sensitivity and specificity) in a PER, updated at least annually.
02
Performance studies
Clinical performance studies where literature and routine data are not enough, conducted under Articles 57 to 77 and Annex XIII.
03
Technical documentation (Annex II & III)
Device description, design and manufacturing, GSPR evidence, risk management, verification and validation and PMS. See IVDR technical documentation.
04
Summary of safety and performance
An SSP under Article 29, validated by the notified body and published in EUDAMED, written for professional users (and lay users for self-tests).
05
PSUR & PMPF
A periodic safety update report under Article 81, updated at least annually and uploaded to EUDAMED for notified body review, plus a PMPF plan and report.
06
Labelling, UDI & EUDAMED
IVDR-compliant labels and IFU, usability evidence for self-tests, UDI carriers on labels, and registration in EUDAMED.
Notified body
IVDR Class C Conformity Assessment Route
Under Article 48(7), Class C manufacturers choose one of two routes:
- Annex IX: QMS audit, plus assessment of the technical documentation of at least one representative device per generic device group.
- Annex X + Annex XI: EU type examination of the device followed by production quality assurance.
“Per generic device group” is stricter than the “per device category” sampling used for Class B. Devices in a generic group share the same intended purpose and technology, so a portfolio usually has more Class C groups than Class B categories, and each group’s file is reviewed before certification.
Extra steps for some Class C devices:
- Self-tests and near-patient tests: the notified body additionally reviews the design documentation, including usability and lay-user labelling (Annex IX, Section 5.1).
- Companion diagnostics: the notified body consults the EMA or a national competent authority on the suitability of the device for the medicinal product (Annex IX, Section 5.2).
How to CE Mark an IVDR Class C Device, Step by Step
- Confirm the classApply Annex VIII Rules 1 to 7, document the rationale and confirm no Class D rule applies.
- Plan the evidenceGap-assess scientific validity, analytical and clinical performance data, and plan any performance studies early.
- Upgrade the QMSExtend EN ISO 13485 with IVDR procedures, PSUR and PMPF processes, and appoint a PRRC.
- Build the technical documentationCompile Annex II and III files per generic device group, the PER, SSP, risk management file and GSPR checklist.
- Apply to a notified bodySubmit under Annex IX or Annex X + XI, complete the QMS audit and technical documentation review, and answer queries.
- Declare conformity and maintainSign the declaration of conformity, CE mark with the NB number, register in EUDAMED, then run PSUR, PMPF and surveillance.
Common Gaps in IVDR Class C Technical Documentation
These are the gaps our team finds most often during Class C gap assessments. Many manufacturers underestimate the evidence needed, and certification can take 18 to 22 months when they surface late.
Insufficient performance data
Analytical or clinical performance studies missing, too small, or run on an earlier design or different specimen types.
Weak or outdated PER
Literature reviews without a protocol, or a PER that has not been updated for current state of the art.
No method comparison
Clinical claims not supported by comparison with a reference or gold-standard method.
GSPR and benefit-risk gaps
Incomplete GSPR checklist or benefit-risk conclusion not linked to performance data.
Usability, labelling and stability
Missing usability validation for self-tests, label validation or shelf-life evidence.
PMS and PMPF
Limited PMPF planning and no system for collecting real-world performance data.
IVDR Class C Transition Deadlines
Many Class C devices were self-declared under the IVD Directive. Regulation (EU) 2024/1860 lets them stay on the market longer, provided they had a valid IVDD declaration of conformity before 26 May 2022, have no significant changes, and meet these milestones:
| Milestone | Deadline | What it means for Class C |
|---|---|---|
| QMS aligned with the IVDR | 26 May 2025 | Your EN ISO 13485 system must already meet IVDR requirements. |
| Formal application lodged with a notified body | 26 May 2026 | The application must already have been submitted. |
| Written agreement signed with the notified body | 26 September 2026 | A signed contract covering the devices in the application. |
| End of transition for Class C legacy devices | 31 December 2028 | Devices may be placed on the market under IVDD status until this date if the conditions above are met. |
IVDR Class C Compared with Class B and Class D
| Class B | Class C | Class D | |
|---|---|---|---|
| Risk | Moderate individual, low public | High individual, moderate public | High individual, high public |
| Technical documentation review | Sampled per device category | Per generic device group | Every device, plus EURL / expert panel where applicable |
| PSUR | No (PMS report) | Yes, at least annually | Yes, at least annually |
| Legacy device deadline | 31 December 2029 | 31 December 2028 | 31 December 2027 |
Software that drives a Class C device follows its class; standalone software is classified in its own right. See IVDR software classification.
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One Partner for Everything IVDR Class C
Regulatory guidance and product technical support combined. We prepare your documentation, coordinate with the notified body and stay with you after the CE mark.
- Classification rationale and performance evidence plan
- Performance evaluation report, SSP and technical documentation
- QMS upgrade, PSUR and PMPF processes
- Notified body application, audit and query support
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FAQs
IVDR Class C: Frequently Asked Questions
What does “technical documentation assessed per generic device group” mean?
Under Annex IX, the notified body reviews the technical documentation of at least one representative device from each generic device group. Devices that share intended purpose and technology form a group, and each group needs its own complete evidence.
What level of performance data is expected for Class C?
Analytical performance (accuracy, precision, LoD, linearity, interference, reproducibility), clinical performance (clinical sensitivity and specificity, comparison with reference methods) and scientific validity, sufficient to support every claim, population and specimen type.
Can literature support clinical evidence, or is a prospective study required?
In many Class C cases a combination of literature, bridging studies and real-world performance data is accepted. New markers, new claims or self-tests often need a clinical performance study.
Do companion diagnostics need extra review?
Yes. For companion diagnostics the notified body must consult the EMA or a national competent authority on the suitability of the device for the medicinal product before issuing the certificate.
Can legacy Class C devices still be sold?
Only until 31 December 2028, and only if the device had a valid IVDD declaration before 26 May 2022, the notified body application was lodged by 26 May 2026 and an agreement signed by 26 September 2026.
Does an IVDR Class C device need a performance study?
Not always. The performance evaluation must show scientific validity, analytical performance and clinical performance (Article 56 and Annex XIII). Existing data, such as peer-reviewed literature, published experience from routine diagnostic testing and earlier studies, can be used where it is sufficient and justified. Where those data leave gaps, a clinical performance study is needed. Interventional studies, or studies with additional invasive procedures or other risks for subjects, have extra requirements under Article 58.
Which post-market documents does an IVDR Class C device need?
Class C manufacturers keep a post-market surveillance plan and post-market performance follow-up (PMPF) plan and report. They also prepare a periodic safety update report (PSUR), updated at least annually and made available to the notified body through EUDAMED (Article 81), and a summary of safety and performance (SSP) validated by the notified body (Article 29). The PMPF findings feed back into the performance evaluation report and the SSP.
Can I3CGlobal support both regulatory documentation and product technical consultation?
Yes. We provide complete IVDR Class C regulatory and product technical consultation, from classification and performance evaluation to notified body certificate.
Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Swathi Tummala, Senior Regulatory Consultant, I3CGLOBAL