Published: 3rd August 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
Understanding IVDR Classification
Determining the correct classification of your in vitro diagnostic medical device (IVD) is one of the most important decisions you will make during your regulatory journey. Under the European Union In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, classification determines almost every aspect of your conformity assessment strategy, from whether you require a Notified Body to the depth of your technical documentation, performance evaluation activities, post-market surveillance obligations and ongoing regulatory oversight.
Unlike the previous In Vitro Diagnostic Directive (IVDD 98/79/EC), which allowed the majority of IVDs to be self-certified, the IVDR introduced a comprehensive risk-based classification system. Many products that were previously self-declared now require independent assessment by a Notified Body before they can be legally placed on the European market.
Manufacturers must therefore understand not only the four IVDR risk classes—Class A, Class B, Class C and Class D—but also how the classification rules contained within Annex VIII are applied in practice. Misclassifying a device can lead to significant regulatory delays, unnecessary certification costs, enforcement action or, in the worst cases, withdrawal of products from the market.
This guide explains how IVDs are classified under the IVDR, explores each classification rule in detail, provides practical examples of common devices and discusses how classification influences your overall regulatory strategy. Whether you are developing a brand-new diagnostic test, transitioning a legacy product from the IVDD or simply trying to understand the regulatory landscape, this article will help you determine the correct classification pathway for your device.
What Is IVDR Classification?
The IVDR classification system is a risk-based framework used to determine the level of regulatory control required for an in vitro diagnostic medical device before it can be placed on the European market.
Rather than classifying devices according to the technology used or the manufacturer, the IVDR focuses on the potential risk posed to patients, users and public health if an IVD were to provide incorrect or misleading results. The greater the potential impact of an incorrect diagnosis or delayed treatment, the higher the classification assigned to the device.
Classification under the IVDR is governed by Annex VIII of Regulation (EU) 2017/746, which contains seven classification rules covering the vast majority of in vitro diagnostic medical devices. These rules assess factors including:
- The intended purpose of the device.
- The disease or condition being investigated.
- Whether the result influences critical clinical decisions.
- The intended user (healthcare professional or lay person).
- Whether the device is used for self-testing or near-patient testing.
- The potential consequences of an incorrect result for individual patients or public health.
The outcome of this assessment determines whether the device falls into Class A, Class B, Class C or Class D, with Class A representing the lowest regulatory risk and Class D representing the highest.
Unlike the previous IVDD, where approximately 80% of IVDs could be self-certified, the IVDR significantly increased regulatory oversight. Today, around 80–90% of IVDs require assessment by a Notified Body before CE marking, making correct classification more important than ever.
Classification should always be documented and justified within the manufacturer’s technical documentation. Regulators and Notified Bodies will expect to see a clear rationale explaining how the relevant Annex VIII classification rule has been applied.
New to the EU IVDR?
If you're looking for a complete introduction to Regulation (EU) 2017/746, including IVD classification, Performance Evaluation, Technical Documentation, conformity assessment, Notified Bodies, UDI, EUDAMED and post-market surveillance, explore our Complete Guide to the EU IVDR.
Why IVDR Classification Matters
Choosing the correct classification is far more than an administrative exercise. It determines the entire regulatory pathway your device must follow before it can be placed on the European market.
From the level of technical documentation required to the extent of Notified Body involvement, classification influences almost every aspect of the conformity assessment process. An incorrect classification can delay certification, increase costs and expose manufacturers to regulatory enforcement if the device is placed on the market under an inappropriate conformity assessment route.
The classification assigned to an IVD directly affects:
Notified Body Involvement
One of the most significant changes introduced by the IVDR is the expansion of mandatory Notified Body oversight. While most devices under the IVDD could be self-certified, the majority of IVDs now require independent conformity assessment before CE marking.
Higher-risk devices are subject to more detailed regulatory scrutiny, including reviews of technical documentation, Quality Management Systems and Performance Evaluation Reports.
Technical Documentation Requirements
Although every manufacturer must prepare technical documentation, higher-risk devices require substantially more supporting evidence. Manufacturers must demonstrate compliance with the General Safety and Performance Requirements (GSPRs), maintain comprehensive design documentation and provide objective evidence that their device performs safely and effectively.
Performance Evaluation
The classification of an IVD influences the depth and complexity of the Performance Evaluation expected by regulators. Higher-risk devices generally require more extensive evidence demonstrating scientific validity, analytical performance and clinical performance.
Manufacturers should also plan for ongoing post-market performance follow-up activities where appropriate to ensure continued compliance throughout the product lifecycle.
How Does Classification Affect Your Performance Evaluation?
Every IVD requires Performance Evaluation, but the depth and complexity of the supporting evidence should reflect the device's intended purpose, classification and risk. Learn how to develop the PEP, demonstrate the three evidence pillars, prepare the PER and plan PMPF in our Complete IVDR Performance Evaluation Guide.
Quality Management System
For most classified devices, manufacturers are expected to operate a robust Quality Management System that supports the design, manufacture and post-market monitoring of their products. In practice, this is typically achieved through compliance with ISO 13485.
Post-Market Surveillance
Classification also influences the level of post-market surveillance expected after the device has been placed on the market. Manufacturers must collect and review real-world performance data, investigate complaints, report serious incidents where required and continually assess whether the benefit-risk profile of the device remains acceptable.
Ultimately, IVDR classification provides the foundation for every subsequent regulatory decision. Determining the correct class at the beginning of a project helps manufacturers plan resources effectively, engage with Notified Bodies where necessary and avoid costly compliance issues later in the product development process.
Understanding the Four IVDR Risk Classes
The IVDR classifies in vitro diagnostic medical devices into four risk classes: Class A, Class B, Class C and Class D. Unlike the previous IVDD, where most IVDs could be self-certified, the IVDR introduced a comprehensive risk-based system that aligns the level of regulatory scrutiny with the potential risk posed by an incorrect diagnostic result.
As the classification increases from Class A to Class D, manufacturers can generally expect:
- Greater regulatory oversight.
- More comprehensive technical documentation.
- Increased performance evaluation requirements.
- Greater Notified Body involvement.
- More stringent post-market surveillance obligations.
The diagram below illustrates how regulatory requirements increase alongside device risk.
Class A IVDs
Class A devices are considered the lowest-risk in vitro diagnostic medical devices under the IVDR. These products generally present minimal risk to patients because they do not directly influence critical diagnostic or treatment decisions.
Most Class A devices do not require Notified Body involvement and may be self-declared by the manufacturer, provided they comply with all applicable IVDR requirements. However, Class A sterile devices are an exception and require assessment by a Notified Body for the aspects relating to sterility.
Typical examples of Class A devices include:
- Laboratory buffers
- Wash solutions
- General specimen receptacles
- Laboratory instruments with no measuring function
- Culture media (where applicable)
- General laboratory accessories
Although Class A devices represent the lowest regulatory risk, manufacturers must still comply with the IVDR by establishing appropriate technical documentation, implementing post-market surveillance procedures and demonstrating conformity with the General Safety and Performance Requirements (GSPRs).
Class B IVDs
Class B devices present a moderate level of risk and generally support diagnostic decisions where an incorrect result is unlikely to lead directly to life-threatening consequences.
Compared with Class A devices, Class B IVDs require significantly greater regulatory oversight. Manufacturers will normally require Notified Body involvement before CE marking and must provide more comprehensive evidence demonstrating device performance and regulatory compliance.
Examples of Class B devices may include:
- Certain vitamin deficiency assays
- Some fertility tests
- Selected infectious disease screening assays
- Clinical chemistry tests with moderate clinical impact
- Certain laboratory reagents
Manufacturers should carefully justify the chosen classification against the Annex VIII rules, as the intended purpose of the device often determines whether it falls into Class B or a higher risk category.
Class C IVDs
Class C devices represent the largest category of IVDs affected by the IVDR and are subject to substantially increased regulatory scrutiny. These devices typically support important clinical decisions where an incorrect result could have serious consequences for individual patients.
Most Class C devices require assessment by a Notified Body before they can be placed on the European market.
Examples include:
- Blood glucose monitoring systems
- Companion diagnostics
- Genetic testing assays
- Cancer biomarker tests
- Many infectious disease assays
- Prenatal screening tests
- Most self-testing devices intended for home use
Manufacturers of Class C devices should expect to prepare detailed technical documentation, comprehensive Performance Evaluation Reports (PERs), robust risk management documentation and an ISO 13485-compliant Quality Management System before certification.
For many organisations transitioning from the IVDD, Class C devices represent the greatest regulatory challenge because products that were previously self-certified now require independent conformity assessment.
New to IVDR Class C Devices?
If you're looking to understand what happens after submitting an IVDR Class C application, including Notified Body review, technical documentation assessment, common non-conformities, requests for additional information, certification timelines and practical next steps, explore our Complete Guide to the IVDR Class C Submission Process.
Class D IVDs
Class D devices represent the highest level of regulatory risk under the IVDR. These products are considered critical because incorrect results may have serious consequences for both individual patients and public health.
As a result, Class D devices undergo the highest level of regulatory scrutiny and require comprehensive conformity assessment by a Notified Body. Additional involvement from EU Reference Laboratories may also apply for certain devices.
Typical examples include:
- HIV screening assays
- Hepatitis B testing
- Hepatitis C testing
- Blood grouping reagents
- Blood donor screening tests
- Tests used to prevent the transmission of life-threatening infectious diseases
Manufacturers developing Class D devices should expect extensive performance evaluation requirements, rigorous quality management processes and ongoing post-market performance monitoring throughout the product lifecycle.
Early engagement with a suitably designated Notified Body is strongly recommended to minimise certification delays and ensure an efficient conformity assessment process.
IVDR Classification at a Glance
|
Classification |
Typical Risk |
Notified Body Required? |
Example Devices |
|
Class A |
Low |
No (except sterile devices) |
Specimen receptacles, laboratory buffers, wash solutions |
|
Class B |
Moderate |
Yes |
Selected clinical chemistry assays, fertility tests, laboratory reagents |
|
Class C |
High |
Yes |
Blood glucose tests, companion diagnostics, genetic tests, most self-tests |
|
Class D |
Highest |
Yes |
HIV assays, blood donor screening tests, blood grouping reagents |
Applying the IVDR Classification Rules
Before determining whether a device falls within Class A, B, C or D, manufacturers should follow several important principles set out in Annex VIII.
Classification is Based on the Intended Purpose
The intended purpose defined by the manufacturer is the starting point for every classification decision. Regulators will assess how the manufacturer describes the device within its Instructions for Use, labelling, promotional materials and technical documentation.
This means that two technically similar devices may receive different classifications if they are intended to be used for different clinical purposes.
For example, a laboratory assay intended for general research purposes is assessed differently from one intended to diagnose a life-threatening infectious disease.
Devices Used Together Are Classified Separately
Where two or more devices are intended to be used together, each device must be classified independently.
For example, an analyser and the reagents used with that analyser do not automatically receive the same classification. Each product must be assessed according to its own intended purpose and the applicable Annex VIII rules.
Accessories Are Classified in Their Own Right
Accessories intended specifically for use with an IVD are not automatically assigned the same classification as the parent device.
Instead, accessories must be classified independently according to their intended purpose and function.
This ensures that the level of regulatory oversight reflects the risk associated with the accessory itself rather than simply mirroring the associated IVD.
Software Requires Separate Consideration
Software that drives or influences the operation of an IVD takes the same classification as the device it controls.
However, standalone software that operates independently must be classified in its own right according to its intended purpose and the applicable Annex VIII rules.
As software continues to play an increasingly important role within modern diagnostics, manufacturers should carefully justify software classification within their technical documentation.
Calibrators and Assigned Controls
Not every product associated with an IVD is classified independently.
Calibrators intended specifically for use with an IVD take the same classification as the associated device.
Similarly, control materials with assigned quantitative or qualitative values intended for a specific analyte or group of analytes are classified in the same class as the associated device.
By contrast, control materials without assigned values are considered separately under Rule 7.
When More Than One Rule Applies
Some devices satisfy the criteria of multiple Annex VIII classification rules.
Where this occurs, manufacturers must apply the rule resulting in the highest classification.
Likewise, where a manufacturer assigns multiple intended purposes to the same device and those intended purposes fall into different risk classes, the highest classification always applies.
Manufacturers should clearly document the reasoning supporting their final classification decision within the technical documentation to demonstrate compliance during regulatory review.
The Seven IVDR Classification Rules
Once the implementing rules have been considered, manufacturers can apply the seven classification rules contained within Annex VIII.
Rule 1 – High-Risk Transmissible Agents (Class D)
Rule 1 applies to devices intended to detect the presence of, or exposure to, transmissible agents where incorrect results could have significant public health consequences.
These devices are classified as Class D where they are intended for:
- Screening blood, blood components, cells, tissues or organs for transfusion or transplantation.
- Detecting life-threatening transmissible agents with a high or suspected high risk of propagation.
- Determining the infectious load of life-threatening diseases where monitoring is critical to patient management.
Typical examples include:
- HIV blood donor screening assays
- Hepatitis B blood screening tests
- Hepatitis C donor screening assays
- Blood donation screening panels
Because these devices help protect both individual patients and the wider population, they receive the highest level of regulatory scrutiny under the IVDR.
Rule 2 – Blood Grouping and Tissue Typing Devices
Rule 2 applies to devices used to determine blood groups or tissue compatibility for transfusion, transplantation or cell administration.
Most devices falling under Rule 2 are classified as Class C.
However, devices intended to determine the following clinically critical blood group markers are classified as Class D:
- ABO blood group system
- Rhesus (Rh) system
- Kell system
- Kidd system
- Duffy system
These markers play a critical role in transfusion safety, and an incorrect result could have life-threatening consequences.
Manufacturers should therefore carefully distinguish between general tissue typing devices and those intended to determine the specific markers identified within Annex VIII.
Rule 3 – Devices Supporting High-Risk Clinical Decisions (Class C)
Rule 3 is the most comprehensive classification rule within the IVDR and applies to a broad range of devices that support significant clinical decisions.
Devices falling within Rule 3 are generally classified as Class C and include those intended for:
- Detection of sexually transmitted infections.
- Detection of infectious agents where an incorrect result could lead to death or severe disability.
- Prenatal immune-status screening.
- Companion diagnostics.
- Cancer screening, diagnosis or staging.
- Human genetic testing.
- Therapeutic drug monitoring where incorrect results could lead to life-threatening treatment decisions.
- Management of patients suffering from life-threatening diseases.
- Screening for congenital disorders.
Because Rule 3 encompasses many modern molecular diagnostics, companion diagnostics and precision medicine applications, manufacturers should pay particular attention to the exact intended purpose described within their technical documentation.
Rule 4 – Self-Testing and Near-Patient Testing
Rule 4 specifically addresses devices intended for self-testing by lay persons.
Self-testing devices are generally classified as Class C.
However, the IVDR provides specific exceptions that are classified as Class B, including:
- Pregnancy tests.
- Fertility tests.
- Cholesterol tests.
- Devices detecting glucose, erythrocytes, leucocytes or bacteria in urine.
Rule 4 also states that devices intended for near-patient testing are classified in their own right using the applicable Annex VIII rules.
Manufacturers should therefore avoid assuming that near-patient use automatically determines the classification.
New to IVDR Home Testing Kits?
If you're looking for a complete introduction to the regulatory requirements for home testing and self-testing IVDs under the EU IVDR, including classification rules, performance evaluation, usability considerations, labelling requirements, Notified Body involvement and CE marking, explore our Complete Guide to IVDR Home Testing Kit Regulations.
Rule 5 – General Laboratory Devices (Class A)
Rule 5 covers lower-risk laboratory products that support diagnostic testing but do not themselves present a significant clinical risk.
These devices are generally classified as Class A and include:
- Products for general laboratory use.
- Buffer solutions.
- Washing solutions.
- General culture media.
- Histological stains.
- Instruments specifically intended for IVD procedures.
- Specimen receptacles.
Although these products represent the lowest risk category, manufacturers must still demonstrate compliance with the IVDR and maintain appropriate technical documentation.
Rule 6 – Devices Not Covered Elsewhere
Rule 6 is the default classification rule.
Any device that is not captured by Rules 1 to 5 is classified as Class B.
Manufacturers should only apply Rule 6 after carefully considering all preceding classification rules and documenting why none of them apply.
Rule 7 – Control Materials Without Assigned Values
Rule 7 applies specifically to control materials that do not have assigned quantitative or qualitative values.
These devices are classified as Class B.
Manufacturers should distinguish these products from assigned-value controls, which follow the classification of the associated IVD under the implementing rules.
How to Determine the Correct Classification for Your IVD
Determining the correct IVDR classification is not simply a matter of identifying a similar device or selecting the classification that appears most appropriate. Manufacturers should follow a structured assessment process based on the intended purpose of the device and the classification rules set out in Annex VIII of Regulation (EU) 2017/746.
A systematic approach helps ensure the classification can be justified during Notified Body reviews and Competent Authority inspections.
Step 1 – Clearly Define the Intended Purpose
Every classification decision begins with the intended purpose defined by the manufacturer.
This should describe:
- What the device is intended to detect or measure.
- The target disease or condition.
- The intended patient population.
- Whether the device is used for screening, diagnosis, monitoring or staging.
- The intended user (healthcare professional or lay person).
- Whether the device is intended for self-testing or near-patient testing.
The intended purpose should be consistent across the Instructions for Use, labelling, technical documentation and marketing materials.
Step 2 – Review the Annex VIII Classification Rules
Once the intended purpose has been established, the manufacturer should systematically review each of the Annex VIII classification rules.
Rather than selecting the rule that appears to fit best, every rule should be considered to determine whether it applies.
If multiple rules apply, the IVDR requires the device to be classified according to the rule resulting in the highest classification.
Step 3 – Consider the Clinical Risk
Classification under the IVDR is fundamentally based upon risk.
Manufacturers should consider questions such as:
- Could an incorrect result delay diagnosis?
- Could it result in inappropriate treatment?
- Could it endanger the patient?
- Could it present a wider public health risk?
- Is the result used to support life-saving clinical decisions?
The greater the potential consequences of an incorrect result, the higher the likely classification.
Step 4 – Document the Classification Rationale
Manufacturers should clearly explain why the selected classification rule applies and why alternative rules were not considered appropriate.
The classification rationale should become part of the technical documentation and should reference the relevant Annex VIII rule together with supporting justification.
A well-documented rationale makes regulatory reviews significantly smoother and demonstrates a systematic approach to compliance.
Step 5 – Confirm the Regulatory Pathway
Once the classification has been established, manufacturers can determine the appropriate conformity assessment procedure.
Classification will influence:
- Whether a Notified Body is required.
- The level of Performance Evaluation expected.
- Technical documentation requirements.
- Post-market surveillance obligations.
- Performance Follow-up activities.
- The overall regulatory timeline.
Confirming the regulatory pathway early allows manufacturers to plan resources, budgets and certification activities more effectively.
Practical Classification Checklist
Before finalising your classification, ask yourself the following questions:
✔ Is the intended purpose clearly defined?
✔ Have all seven Annex VIII classification rules been considered?
✔ Have the Annex VIII implementing rules been applied?
✔ Could more than one classification rule apply?
✔ Have you selected the highest applicable classification?
✔ Is the classification rationale fully documented?
✔ Does the selected conformity assessment route match the classification?
✔ Have you confirmed whether Notified Body involvement is required?
Completing these checks before beginning conformity assessment can prevent costly delays and reduce the likelihood of regulatory challenges later in the project.
New to IVD Regulatory Consultancy?
If you're looking to understand how experienced regulatory consultants can help you achieve and maintain IVDR compliance, including regulatory strategy, IVD classification, Performance Evaluation, Technical Documentation, Notified Body support and post-market compliance, explore our Complete Guide to IVD Regulatory Consultancy.
How Classification Influences Your Regulatory Strategy
Choosing the correct classification does much more than determine the label assigned to your device. It shapes the entire regulatory pathway that follows, influencing everything from conformity assessment and technical documentation to Performance Evaluation and post-market obligations.
Manufacturers who understand these implications early in development are better positioned to plan resources, avoid delays and achieve a smoother certification process.
Notified Body Involvement
One of the most significant consequences of classification is whether an independent Notified Body must assess your device before CE marking.
- Class A (non-sterile) devices are generally self-certified by the manufacturer.
- Class A sterile, Class B, Class C and Class D devices require varying levels of Notified Body involvement.
- Class D devices may also involve EU Reference Laboratories for certain high-risk assays.
Engaging with a Notified Body early can significantly reduce certification delays, particularly for higher-risk devices.
Performance Evaluation Requirements
As the classification increases, so does the expectation for robust evidence demonstrating device performance.
Manufacturers may need to produce:
- A Performance Evaluation Plan (PEP).
- A Performance Evaluation Report (PER).
- Scientific validity evidence.
- Analytical performance studies.
- Clinical performance evidence.
- Post-Market Performance Follow-up (PMPF).
The extent of this evidence should be proportionate to the classification and intended purpose of the device.
Technical Documentation
Higher-risk devices require increasingly comprehensive technical documentation.
Manufacturers should expect to prepare detailed evidence covering:
- Device description and specification.
- Design and manufacturing information.
- Risk management documentation.
- Performance Evaluation.
- General Safety and Performance Requirements (GSPRs).
- Labelling and Instructions for Use.
- Post-market surveillance.
The technical documentation should clearly demonstrate conformity with the IVDR and support the chosen classification.
Quality Management System
Manufacturers of higher-risk IVDs are generally expected to operate an effective Quality Management System, typically aligned with ISO 13485.
A well-implemented QMS supports:
- Design control.
- Document management.
- Supplier oversight.
- Corrective and Preventive Actions (CAPA).
- Internal audits.
- Management review.
- Continuous improvement.
Although not mandated by the IVDR itself, ISO 13485 is widely recognised as the benchmark for demonstrating compliance with Article 10 quality management requirements.
Real World IVDR Classification Examples
Although the Annex VIII classification rules provide the legal framework for classifying IVDs, manufacturers often find it easier to understand the requirements by looking at practical examples.
The examples below illustrate how common in vitro diagnostic devices are typically classified under the IVDR. However, manufacturers should remember that classification is always determined by the intended purpose of the individual device. Similar technologies may fall into different classifications depending on how they are intended to be used.
Pregnancy Tests
Most pregnancy tests intended for self-testing by lay users are classified as Class B under Rule 4.
Although these devices are intended for home use, the IVDR specifically identifies pregnancy testing as an exception to the general rule that self-testing devices are classified as Class C.
Manufacturers should still ensure that usability, labelling and Instructions for Use are suitable for lay users and supported by appropriate performance evidence.
Blood Glucose Monitoring Systems
Blood glucose monitoring devices are generally classified as Class C under Rule 3 because inaccurate results may directly influence clinical decisions and patient management.
However, glucose detection in urine for self-testing falls within the specific exceptions listed under Rule 4 and is generally classified as Class B.
Manufacturers should therefore distinguish carefully between blood glucose monitoring and urine glucose testing when determining classification.
COVID-19 Diagnostic Tests
COVID-19 diagnostic assays are generally classified as Class C because they detect infectious agents where inaccurate results may significantly influence patient management and public health decisions.
Manufacturers should carefully assess the intended purpose against Rule 3, particularly where tests are intended for screening, diagnosis or monitoring.
Companion Diagnostics
Companion diagnostics are specifically identified within Rule 3 and are classified as Class C.
These devices are used to determine whether a patient is suitable for a particular medicinal product and therefore directly influence treatment decisions.
Because incorrect results could lead to inappropriate therapy, comprehensive performance evaluation and Notified Body assessment are required.
Human Genetic Tests
Devices intended for human genetic testing are classified as Class C under Rule 3.
This includes many tests used for inherited disorders, disease susceptibility and personalised medicine applications.
Manufacturers should ensure that both analytical performance and clinical performance evidence adequately support the intended purpose.
Cancer Biomarker Tests
IVDs used for cancer screening, diagnosis or disease staging generally fall within Class C.
These devices often influence treatment decisions, making accurate performance evaluation particularly important.
Examples include assays used to identify tumour markers, genetic mutations or biomarkers supporting oncology treatment.
HIV Blood Donor Screening Tests
Devices used to screen donated blood for HIV are classified as Class D under Rule 1.
These products protect both individual recipients and public health by helping prevent transmission of life-threatening infectious diseases through blood transfusion.
As a result, they are subject to the highest level of regulatory scrutiny under the IVDR.
Blood Grouping Reagents
Blood grouping reagents may be classified as either Class C or Class D, depending on the specific marker being determined.
Devices intended to determine markers such as ABO, Rhesus, Kell, Kidd or Duffy fall within Class D, while other blood grouping or tissue typing devices generally fall within Class C under Rule 2.
Manufacturers should therefore carefully review the intended purpose against the specific requirements of Annex VIII.
General Laboratory Buffers and Washing Solutions
General laboratory buffers, washing solutions and similar laboratory products are typically classified as Class A under Rule 5, provided they possess no critical diagnostic characteristics and are intended to support in vitro diagnostic procedures.
Although these products represent the lowest risk category, manufacturers must still demonstrate compliance with the applicable requirements of the IVDR.
Specimen Receptacles
Specimen receptacles specifically intended for collecting and preserving samples for in vitro diagnostic examination are classified as Class A under Rule 5.
Manufacturers should ensure that the intended purpose clearly reflects their use in supporting diagnostic procedures.
Summary of Common IVD Classifications
|
Device Type |
Typical Classification |
Primary Rule |
|
Laboratory buffers |
Class A |
Rule 5 |
|
Specimen receptacles |
Class A |
Rule 5 |
|
Pregnancy self-tests |
Class B |
Rule 4 |
|
Fertility self-tests |
Class B |
Rule 4 |
|
Cholesterol self-tests |
Class B |
Rule 4 |
|
Blood glucose monitoring systems |
Class C* |
Rule 3 |
|
COVID-19 diagnostic assays |
Class C |
Rule 3 |
|
Companion diagnostics |
Class C |
Rule 3 |
|
Human genetic tests |
Class C |
Rule 3 |
|
Cancer biomarker assays |
Class C |
Rule 3 |
|
Blood donor HIV screening assays |
Class D |
Rule 1 |
|
ABO blood grouping reagents |
Class D |
Rule 2 |
Important: These examples are provided for general guidance only. Manufacturers should always determine classification by applying the Annex VIII implementing rules and classification rules to the specific intended purpose of their own device.
New to MDR & IVDR Liability?
If you're looking to understand the legal responsibilities of manufacturers, Authorised Representatives, importers and distributors under the EU MDR and IVDR, including economic operator obligations, regulatory liability, compliance responsibilities and the consequences of non-compliance, explore our Complete Guide to MDR & IVDR Liability.
Common IVDR Classification Mistakes
Incorrect classification is one of the most common reasons for delays during IVDR conformity assessment. A misclassified device can result in the wrong conformity assessment procedure being followed, insufficient technical documentation, unnecessary certification costs or regulatory enforcement action after the device has been placed on the market.
Fortunately, many of these issues can be avoided by understanding the Annex VIII classification rules and documenting a robust classification rationale at an early stage of development.
Below are some of the most common mistakes encountered by manufacturers transitioning to the IVDR.
Assuming Your IVDD Classification Still Applies
One of the biggest challenges following the introduction of the IVDR has been the transition from the previous In Vitro Diagnostic Directive (IVDD).
Under the IVDD, approximately 80% of IVDs could be self-certified by the manufacturer. The IVDR introduced a new risk-based classification system that significantly increased the number of devices requiring Notified Body involvement.
Many devices that were previously self-declared under the IVDD are now classified as Class B, Class C or Class D under the IVDR.
Manufacturers should therefore avoid assuming that an existing CE-marked device retains the same regulatory pathway under the new legislation.
Focusing on the Technology Instead of the Intended Purpose
The IVDR does not classify devices based solely on the technology they use.
Instead, classification is determined primarily by the manufacturer’s intended purpose.
For example, two devices using identical laboratory technology may fall into different classifications depending on:
- The disease being investigated.
- The intended patient population.
- Whether the result influences life-saving clinical decisions.
- Whether the device is intended for self-testing.
- The potential consequences of an incorrect result.
The intended purpose should always be clearly defined before attempting to determine the classification.
Applying Only One Classification Rule
Manufacturers sometimes identify one Annex VIII rule that appears relevant and stop their assessment there.
However, Annex VIII requires manufacturers to consider all applicable implementing rules and classification rules before determining the final classification.
Where more than one rule applies, the IVDR requires the device to be assigned the highest applicable classification.
Documenting this assessment demonstrates that the classification has been determined systematically rather than selected arbitrarily.
Misunderstanding Self-Testing Devices
Many manufacturers assume that every self-testing device automatically falls within Class C.
This is not correct.
While most self-testing devices are classified as Class C under Rule 4, the IVDR specifically identifies several exceptions that are classified as Class B, including:
- Pregnancy tests.
- Fertility tests.
- Cholesterol tests.
- Tests detecting glucose, erythrocytes, leucocytes or bacteria in urine.
Carefully reviewing the wording of Rule 4 is essential before assigning a classification to any self-testing device.
Overlooking Software Classification
As software continues to play an increasingly important role within modern diagnostics, manufacturers should carefully consider how software is classified.
Software that drives or influences the use of an IVD generally takes the same classification as the associated device.
However, standalone software must be classified independently according to its intended purpose.
Manufacturers should clearly document the software architecture and justify the classification within the technical documentation.
Incorrectly Classifying Accessories
Accessories are frequently misunderstood during classification.
Although accessories are supplied for use with an IVD, they are generally classified in their own right according to their intended purpose.
Manufacturers should therefore avoid assuming that an accessory automatically shares the classification of the associated device.
The only exceptions are certain products such as calibrators and assigned-value control materials, which follow the classification of the associated IVD under the Annex VIII implementing rules.
Failing to Document the Classification Rationale
Even where the final classification is correct, manufacturers sometimes fail to explain how that decision was reached.
The classification rationale should become part of the technical documentation and should include:
- The intended purpose.
- The implementing rules considered.
- The Annex VIII rule applied.
- Justification for the selected classification.
- Reasons why alternative rules were not considered applicable.
A clear rationale makes regulatory reviews significantly more efficient and demonstrates a structured approach to compliance.
Waiting Too Long to Engage a Notified Body
For many Class B, Class C and Class D devices, manufacturers delay discussions with a Notified Body until technical documentation has been completed.
However, early engagement can help identify classification questions, conformity assessment expectations and documentation requirements before significant resources have been invested.
This is particularly valuable where the classification is not straightforward or where novel technologies are involved.
Key Takeaways
Avoiding common classification mistakes can save manufacturers significant time, cost and regulatory effort.
Before finalising the classification of your IVD, make sure you:
- Clearly define the intended purpose.
- Apply the Annex VIII implementing rules.
- Assess all seven classification rules.
- Select the highest applicable classification where multiple rules apply.
- Document the classification rationale.
- Confirm the appropriate conformity assessment procedure.
- Seek specialist regulatory advice if the classification is uncertain.
Taking a structured approach at the beginning of development helps reduce delays, supports smoother Notified Body reviews and provides a strong foundation for successful IVDR compliance.
New to Article 10 of the EU IVDR?
If you're looking for a complete introduction to the general obligations of IVD manufacturers under Regulation (EU) 2017/746, including quality management systems, Technical Documentation, Performance Evaluation, risk management, post-market surveillance, vigilance and regulatory responsibilities, explore our Complete Guide to Article 10 of the EU IVDR.
What Happens After You Have Classified Your IVD?
Determining the correct IVDR classification is a significant milestone, but it is only the beginning of the regulatory journey. Once the classification has been established, manufacturers must follow the conformity assessment procedure applicable to that class and demonstrate compliance with all relevant requirements of Regulation (EU) 2017/746.
The classification of your device will determine the level of regulatory oversight required before your product can be placed on the European market.
Conformity Assessment
Every IVD must undergo an appropriate conformity assessment before CE marking.
The conformity assessment route depends on the classification of the device and determines whether the manufacturer may self-declare conformity or whether independent assessment by a Notified Body is required.
In general:
- Class A (non-sterile) devices may be self-certified by the manufacturer.
- Class A sterile devices require Notified Body assessment for the aspects relating to sterility.
- Class B, Class C and Class D devices require Notified Body involvement before CE marking.
Manufacturers should identify the appropriate conformity assessment route as early as possible to support project planning and certification timelines.
Performance Evaluation
Classification also determines the level of evidence required to demonstrate that the device performs safely and effectively.
Manufacturers should establish and maintain a Performance Evaluation that demonstrates:
- Scientific validity.
- Analytical performance.
- Clinical performance.
The extent of this evidence should be proportionate to the intended purpose and classification of the device.
For many Class C and Class D devices, Performance Evaluation represents one of the most significant components of the technical documentation and should be planned from the earliest stages of development.
Technical Documentation
The technical documentation should clearly demonstrate conformity with the IVDR and provide objective evidence supporting the safety and performance of the device.
Although the depth of documentation varies according to classification, manufacturers should generally prepare documentation covering:
- Device description and specification.
- Design and manufacturing information.
- Risk management.
- Performance Evaluation.
- General Safety and Performance Requirements (GSPRs).
- Verification and validation activities.
- Labelling and Instructions for Use.
- Post-market surveillance planning.
The classification rationale itself should also form part of the technical documentation and explain how the applicable Annex VIII rules were applied.
Quality Management System
As regulatory oversight increases, so does the expectation for a mature Quality Management System.
Most manufacturers of Class B, Class C and Class D devices operate a Quality Management System that complies with ISO 13485, supporting activities such as:
- Design and development.
- Supplier management.
- Document control.
- Corrective and Preventive Actions (CAPA).
- Internal audits.
- Management review.
- Continuous improvement.
A well-implemented QMS not only supports IVDR compliance but also provides confidence during Notified Body assessments.
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Post-Market Surveillance
Regulatory obligations continue long after CE marking has been achieved.
Manufacturers must monitor the safety and performance of their devices throughout their lifecycle by implementing appropriate post-market surveillance activities.
Depending on the classification and intended purpose of the device, this may include:
- Complaint handling.
- Trend reporting.
- Vigilance reporting.
- Performance monitoring.
- Periodic review of scientific literature.
- Updating the Performance Evaluation.
- Post-Market Performance Follow-up (PMPF), where appropriate.
These activities help ensure that the benefit-risk profile of the device remains acceptable and that emerging safety or performance issues are identified promptly.
IVDR Classification Is the Foundation of Your Regulatory Strategy
Choosing the correct classification is far more than a regulatory exercise—it establishes the framework for every stage of the conformity assessment process.
From determining whether a Notified Body is required to defining the scope of Performance Evaluation, technical documentation and post-market surveillance, classification influences almost every aspect of IVDR compliance.
Manufacturers that invest time in establishing and documenting the correct classification at the outset are better positioned to achieve a smoother certification process, reduce regulatory delays and maintain compliance throughout the product lifecycle.
Conclusion
Correctly classifying an in vitro diagnostic medical device under the IVDR is one of the most important decisions a manufacturer will make during product development. The classification assigned to an IVD determines the regulatory pathway, the level of evidence required, the extent of Notified Body involvement and the ongoing obligations that apply throughout the device lifecycle.
By understanding the Annex VIII implementing rules, applying the seven classification rules systematically and documenting a clear classification rationale, manufacturers can establish a strong foundation for successful IVDR compliance. Early planning not only reduces regulatory uncertainty but also helps avoid costly delays during conformity assessment.
As the IVDR continues to reshape the European regulatory landscape, taking a structured and evidence-based approach to classification has never been more important. Whether you are developing a novel diagnostic technology or transitioning an existing device from the IVDD, investing time in determining the correct classification will support a smoother certification process and long-term regulatory success.
Frequently Asked Questions About IVDR Classification
IVDR classification is the risk-based system established under Regulation (EU) 2017/746 to determine the level of regulatory control required for an in vitro diagnostic medical device (IVD). Devices are classified as Class A, B, C or D according to the intended purpose of the device and the potential risk posed by an incorrect result.
The IVDR classification rules are contained within Annex VIII of Regulation (EU) 2017/746.
Manufacturers should apply the Annex VIII implementing rules before assessing the seven classification rules to determine the appropriate class for their device.
Annex VIII contains:
- Ten implementing rules.
- Seven classification rules.
Manufacturers should consider both when determining the correct classification of their IVD
The four IVDR classes represent increasing levels of regulatory risk.
- Class A – Lowest risk.
- Class B – Moderate risk.
- Class C – High individual patient risk.
- Class D – Highest patient and public health risk.
As classification increases, manufacturers can generally expect greater regulatory scrutiny, more comprehensive technical documentation and increased Notified Body involvement.
No.
Generally:
- Class A (non-sterile) devices may be self-certified.
- Class A sterile, Class B, Class C and Class D devices require Notified Body involvement before CE marking.
Manufacturers should confirm the applicable conformity assessment procedure based on the classification of their device.
No.
Although most self-testing devices are classified as Class C, Rule 4 provides several important exceptions.
The following self-testing devices are generally classified as Class B:
- Pregnancy tests.
- Fertility tests.
- Cholesterol tests.
- Devices detecting glucose, erythrocytes, leucocytes or bacteria in urine.
No.
Near-patient testing devices are classified in their own right using the applicable Annex VIII classification rules.
Manufacturers should therefore determine the classification based on the intended purpose rather than assuming near-patient testing automatically determines the risk class.
Yes.
Standalone software is classified independently according to its intended purpose.
Software that drives or influences the operation of another IVD generally takes the same classification as the associated device.
Yes.
If multiple Annex VIII classification rules apply, the IVDR requires the manufacturer to assign the highest applicable classification.
Similarly, where a device has multiple intended purposes resulting in different classifications, the highest classification must be applied.
Manufacturers should prepare a documented classification rationale within the technical documentation.
This should explain:
- The intended purpose.
- The implementing rules considered.
- The Annex VIII classification rule applied.
- Why alternative rules were not applicable.
The justification supporting the final classification.
Incorrect classification may result in:
- Delays to certification.
- Additional regulatory costs.
- Notified Body non-conformities.
- Regulatory enforcement action.
- Product withdrawal from the market.
- Delays in obtaining CE marking.
Establishing the correct classification at the beginning of development helps avoid these issues.
Manufacturers should determine the classification as early as possible during product development.
Classification influences the conformity assessment procedure, technical documentation, Performance Evaluation, Quality Management System requirements and overall regulatory strategy.
Determining the classification early allows manufacturers to plan resources, engage with a Notified Body where required and avoid unnecessary delays.
No.
Accessories are generally classified in their own right according to their intended purpose.
However, calibrators and assigned-value control materials follow the classification of the associated device in accordance with the Annex VIII implementing rules.
No.
Classification is based primarily on the intended purpose of the device and the associated level of risk rather than the underlying technology.
Two technically similar devices may receive different classifications if they are intended for different clinical applications.
Yes.
Patient Guard provides regulatory consultancy to help manufacturers determine the correct IVDR classification, prepare technical documentation, develop Performance Evaluation strategies and navigate the conformity assessment process. Whether you are developing a new IVD or transitioning an existing product from the IVDD, our regulatory specialists can help you establish a clear and compliant pathway to market.
References
This guide is based on the following legislation, international standards and official regulatory guidance relating to the classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Provides the legal framework for IVDR classification, including the Annex VIII classification rules, conformity assessment procedures and regulatory requirements that determine the classification of in vitro diagnostic medical devices. |
| European Commission | MDCG Endorsed Documents and Other Guidance | Provides official Medical Device Coordination Group (MDCG) guidance supporting IVDR classification, conformity assessment, performance evaluation and technical documentation. |
| European Commission | Notified Bodies for Medical Devices | Provides official information on the designation and responsibilities of Notified Bodies responsible for conformity assessment of Class B, Class C and Class D IVDs. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements supporting manufacturers throughout the IVDR conformity assessment process. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | Provides the internationally recognised framework for identifying, evaluating and controlling risks throughout the lifecycle of medical devices, supporting the risk management activities required under the IVDR. |
IVDR classification requirements and regulatory guidance continue to evolve. Manufacturers should always consult the latest published legislation, recognised standards and official guidance when determining the classification of in vitro diagnostic medical devices and planning their regulatory strategy.
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