IVDR Class B Devices
IVDR Class B covers in vitro diagnostic devices with moderate individual risk and low public health risk. It is the default class under Rule 6, so most routine clinical chemistry, haematology and immunoassay tests sit here. Unlike the old IVD Directive, every IVDR Class B device needs a notified body before it can carry the CE mark. This guide explains the requirements, the conformity assessment route, the transition deadlines and how I3CGlobal gets Class B devices certified.
What is an IVDR Class B Device?
Under Regulation (EU) 2017/746, IVDs are placed in four risk classes, A to D. Class B IVDR devices present a moderate risk to the individual patient and a low risk to public health. An incorrect result could affect a patient's management, but it is unlikely to lead to death, severe disability or an outbreak.
Three Annex VIII rules lead to Class B:
- Rule 6: any device not covered by Rules 1 to 5 is Class B. This is why Class B is the largest group of IVDs.
- Rule 7: controls without a quantitative or qualitative assigned value are Class B.
- Rule 4 exceptions: self-tests for pregnancy, fertility, cholesterol and for glucose, erythrocytes, leucocytes or bacteria in urine are Class B instead of Class C.
If your device detects a transmissible agent, is used for blood grouping, cancer, genetic or prenatal testing, or is a self-test outside the exceptions above, it belongs to a higher class. Work through all the rules on our IVDR classification guide before you settle on Class B, because the notified body will verify the class you choose.
Typical IVDR Class B Devices
These products are commonly placed in IVDR Class B. The final class always depends on the intended purpose you state in the labelling and instructions for use.
Routine clinical chemistry
Glucose, HbA1c, lipids, liver and kidney panels, electrolytes and enzymes run in laboratories and hospitals (Rule 6).
Haematology & coagulation
Full blood count reagents, haemoglobin, PT/INR and APTT reagents for laboratory use (Rule 6).
Hormones & vitamins
Thyroid hormones, vitamin D, ferritin, B12 and similar immunoassays (Rule 6).
Self-tests under the Rule 4 exceptions
Pregnancy and ovulation tests, cholesterol self-tests, and urine glucose or urine infection dipsticks for home use.
Controls without assigned values
Quality control materials supplied without a quantitative or qualitative target value (Rule 7).
Urinalysis & general immunology
Urine strips for laboratory use, CRP, rheumatoid factor and other markers not captured by Rule 3.
Not sure whether your product is Class A, B or C? Compare with the IVDR Class A and IVDR Class C guides, or ask our IVDR consultants for a written classification rationale.
Key Requirements for IVDR Class B Certification
Manufacturers of IVDR Class B devices must demonstrate compliance with the General Safety and Performance Requirements in Annex I, run an EN ISO 13485 quality management system aligned with the IVDR, and prepare complete technical documentation under Annexes II and III. The main building blocks are:
GSPR compliance (Annex I)
A GSPR checklist showing how each applicable requirement is met, with the standards, test reports and documents that prove it.
Quality management system
An EN ISO 13485:2016 QMS extended with IVDR-specific procedures for PMS, vigilance, UDI, performance evaluation and the person responsible for regulatory compliance (PRRC).
Technical documentation (Annex II & III)
Device description, design and manufacturing information, GSPR evidence, benefit-risk and risk management, verification and validation, and PMS documentation. See our IVDR technical documentation service.
Performance evaluation
Scientific validity, analytical performance and clinical performance evidence compiled in a performance evaluation report (PER) with a PMPF plan.
Validation, stability & usability
Manufacturing process validation, sample and reagent stability studies, software validation where relevant, and usability evaluation, especially for self-tests.
Labelling, UDI & EUDAMED
IVDR-compliant labels and IFU, a UDI assigned to each device, and registration of the manufacturer and devices in EUDAMED.
IVDR Class B Conformity Assessment Route
IVDR Class B devices cannot be self-certified. The manufacturer selects a notified body route and submits an application covering its Class B devices grouped by device category:
- Annex IX (most common): Chapter I audit of the quality management system, plus Chapter II assessment of the technical documentation of at least one representative device per device category (Annex IX, Sections 4 and 5.1).
- Annex X + Annex XI: type examination of a representative device followed by production quality assurance. This route is used less often for Class B.
The notified body does not review every Class B file before certification. It audits the QMS, samples the technical documentation of one representative device from each category, and then continues sampling further files during surveillance audits over the certificate's five-year cycle. Every file must therefore be audit-ready, not only the one you expect to be sampled.
After a successful assessment, the manufacturer signs the Annex IV declaration of conformity, applies the CE mark with the notified body number, registers the devices in EUDAMED and can place them on the EU market.
What the notified body reviews in a sampled Class B technical file
"Technical assessment per device category" means the notified body reviews the documentation of one device chosen to represent each category, not a single file for your whole portfolio. For the sampled device it checks:
- Analytical and clinical performance evidence and the performance evaluation report
- Biological safety, sample stability and shelf-life data
- Risk management file (ISO 14971)
- Usability and software documentation where applicable
- Verification and validation data, including process validation
- GSPR compliance evidence
- Labelling, instructions for use and UDI
- Post-market surveillance and PMPF planning
How IVDR Class B Devices Are Grouped for Notified Body Sampling
Annex IX asks the notified body to sample technical documentation for each "device category" in a Class B application, so the way you group your portfolio matters. See our guide to IVDR Class B device categories for the category codes notified bodies use. Notified bodies generally define a category by the technology and the type of analyte, for example "clinical chemistry reagents, enzymatic, open-channel analysers" or "lateral-flow immunoassay self-tests". A manufacturer with 60 IVDR Class B reagents may therefore have only five or six categories, and will see one file per category assessed at certification and the remainder sampled over the surveillance cycle.
Group by shared evidence
Devices that share a platform, manufacturing process, validation approach and risk profile belong together. The representative device should carry the most complete evidence in the group.
Keep self-tests separate
Rule 4 exception self-tests have usability, lay-user labelling and IFU requirements that laboratory reagents do not, so they form their own categories.
Match the technical documentation structure
Build each file with the same table of contents and cross-reference shared documents, so a sampled file can be assembled quickly and reviewed without gaps.
Changing categories after the application has been lodged can delay the assessment, so we agree the grouping with the notified body before submission. For manufacturers moving a large IVDD portfolio to IVDR Class B, this grouping exercise is often the single biggest time saver in the whole project.
How to CE Mark an IVDR Class B Device, Step by Step
- Confirm the classApply Annex VIII Rules 1 to 7 and document the rationale. If a higher rule applies, the device is not Class B.
- Upgrade the QMSExtend your EN ISO 13485 system with IVDR procedures and appoint a person responsible for regulatory compliance.
- Build the technical documentationCompile Annex II and III documentation, the GSPR checklist, risk management file and performance evaluation report.
- Appoint an EU authorised representativeRequired for manufacturers outside the EU before devices are placed on the market.
- Apply to a notified bodySelect an IVDR-designated notified body, submit the Annex IX application by device category and complete the QMS audit and file assessment.
- Declare conformity and registerSign the declaration of conformity, apply the CE mark, assign UDIs and register in EUDAMED, then maintain PMS and surveillance audits.
Class B IVDR Timeline, Cost and QMS Changes
A first IVDR Class B certification typically takes 9 to 15 months from gap assessment to certificate, depending on how much performance data already exists and on notified body capacity. Notified body fees are charged for the QMS audit, each sampled technical file and annual surveillance, so grouping devices into sensible categories directly affects cost. Our IVDR CE certification cost page gives indicative budgets by class.
The QMS changes needed for IVDR Class B go beyond a certificate update. Compared with an IVDD-era EN ISO 13485 system, manufacturers must add or strengthen:
- A documented performance evaluation process with a PER and PMPF plan for every device
- Post-market surveillance, vigilance and trend reporting procedures aligned with IVDR Articles 78 to 83
- UDI assignment and EUDAMED registration procedures
- A person responsible for regulatory compliance (PRRC) with defined qualifications
- Supplier and subcontractor controls for outsourced design, manufacturing and testing
- Management of the technical documentation structure by device category so that notified body sampling is straightforward
Where the official rules are
The classification rules are in Annex VIII and the Class B conformity assessment procedures in Annexes IX to XI of Regulation (EU) 2017/746 on EUR-Lex. The extended transition periods are set out in Regulation (EU) 2024/1860, and the European Commission publishes guidance on IVDR implementation and the MDCG classification guidance (MDCG 2020-16) on its medical devices pages.
Common Notified Body Findings on IVDR Class B Files
Because notified bodies sample Class B technical documentation, a weak file can surface at any surveillance audit. These are the findings we see most often on IVDR Class B submissions, and how to avoid them.
Thin scientific validity
The PER cites product inserts instead of peer-reviewed literature or guidelines linking the analyte to the clinical condition. Build a literature search protocol and report.
Analytical performance gaps
Missing precision, linearity, interference, cross-reactivity or stability studies, or studies run on an earlier design. Map every GSPR to a current, traceable study.
Risk management not linked to performance
Hazards from incorrect results are listed, but risk controls are not verified against performance data or usability outcomes.
Legacy IVDD labelling
Labels and IFU still follow the IVDD, lacking UDI carriers, the IVDR symbols or the new content requirements of Annex I Chapter III.
Incomplete PMS system
No PMS plan or periodic safety update, and no PMPF plan explaining why further clinical performance data is or is not needed.
Inconsistent device grouping
Device categories in the application do not match the technical documentation structure, slowing down sampling and review.
Our pre-submission gap assessment reviews every IVDR Class B file against the notified body's checklist, so the sampled device passes and the rest of the portfolio is ready when it is called.
IVDR Class B Transition Deadlines
Many devices that were self-declared under the IVD Directive are IVDR Class B today and need a notified body for the first time. Regulation (EU) 2024/1860 gives these legacy devices extra time, provided they had a valid IVDD declaration of conformity before 26 May 2022 and meet the following conditions:
| Milestone | Deadline | What it means for Class B |
|---|---|---|
| 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 2027 | The application for Annex IX assessment must be submitted. |
| Written agreement signed with the notified body | 26 September 2027 | A signed contract covering the devices in the application. |
| End of transition for Class B legacy devices | 31 December 2029 | Devices may be placed on the market under IVDD certificates until this date if the conditions above are met. |
IVDR Class B Compared with Class A and Class C
| Class A | Class B | Class C | |
|---|---|---|---|
| Risk | Low individual, low public | Moderate individual, low public | High individual, moderate public |
| Notified body | No (sterile aspects only for Class A sterile) | Yes: QMS audit plus sampled technical documentation per category | Yes: QMS audit plus technical documentation per generic device group |
| Typical examples | Buffers, media, instruments, specimen tubes | Routine chemistry, haematology, pregnancy self-tests | Cancer, genetic, infectious disease and most self-tests |
| Legacy device deadline | Not applicable (sterile: 31 Dec 2029) | 31 December 2029 | 31 December 2028 |
Software used with Class B devices follows the class of the device it drives; standalone software is classified on its own. See IVDR software classification.
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Regulatory guidance and product technical support combined. We prepare manufacturers for notified body assessment and stay with you through surveillance.
- Classification rationale and GSPR checklist
- Technical documentation and PER
- QMS upgrade to IVDR and PRRC support
- Notified body application, audit and query support
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IVDR Class B: Frequently Asked Questions
Can we continue selling our Class B devices during the transition?
Yes, if the device had a valid declaration of conformity under the IVDD before 26 May 2022 and you meet the milestones: IVDR-aligned QMS by 26 May 2025, notified body application by 26 May 2027 and a written agreement by 26 September 2027. Such devices may be placed on the market until 31 December 2029.
Does every IVDR Class B device need a notified body?
Yes. Class B is the lowest class that requires notified body involvement. The notified body audits the QMS and assesses sampled technical documentation per device category under Annex IX.
What does “technical assessment per device category” mean?
The notified body groups your Class B devices into categories and reviews the technical documentation of one representative device from each category, rather than one file for the whole range. It samples further files during surveillance audits.
Are pregnancy and glucose self-tests Class B or Class C?
Pregnancy, fertility and cholesterol self-tests, and urine tests for glucose, erythrocytes, leucocytes or bacteria, are Class B under the Rule 4 exceptions. Other self-tests, including blood glucose meters, are Class C.
Is a performance evaluation report required for Class B?
Yes. Every IVD, including Class B, needs a performance evaluation covering scientific validity, analytical performance and clinical performance, with a post-market performance follow-up plan. The depth of evidence is lower than for Class C and D.
Can I3CGlobal support both regulatory documentation and product technical consultation?
Yes. We provide complete IVDR Class B regulatory and product technical consultation as a combined service, from classification to notified body certificate.
Updated | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Swathi Tummala, Senior Regulatory Consultant, I3CGLOBAL