Europe Regulatory ServicesMedical device classification under Regulation (EU) 2017/745 (EU MDR) is a systematic, risk-based process that determines the regulatory class of a device according to its intended purpose, design characteristics, invasiveness, duration of use, and potential risks to patients and users.
Annex VIII of the EU Regulations, medical devices and IVD medical devices are classified into 4 different classes. The classification determines the applicable conformity assessment requirements and influences the level of regulatory scrutiny required before a device can be placed on the European Union market.
The Medical Device Coordination Group (MDCG) guidance document MDCG 2021-24 Rev.1 provides practical guidance for applying the classification rules consistently.
The following steps outline the classification process:
Services We Provide for Classification
- Medical Device (MD) Classification as per EU MDR 2017/745, Annex VIII.
- In Vitro Diagnostic (IVD) Classification as per EU IVDR 2017/746, Annex VIII.
- Well-Established Technology (WET) Assessment for applicable devices.
- WET Eligibility Assessment against applicable regulatory provisions.
- MDR Classification Rule Identification and Justification.
- IVDR Risk Classification into Class A, B, C, and D.
- Intended Purpose and Device Characteristics Assessment.
- Classification Rationale Preparation for technical documentation.
- Conformity Assessment Route Determination.
Step 1: Define the Intended Purpose
The first and most important step is to establish and define the manufacturer’s intended purpose, including the medical indication, target patient population, intended users, conditions of use, mode of action, anatomical site, and duration of use. The intended purpose must be consistent with the device design, technical documentation, labelling, and instructions for use (IFU).
Why this matters: Classification is based on the intended purpose and the applicable criteria in Annex VIII. A change in the intended purpose or relevant design characteristics can result in a different classification.
Step 2: Determine the Device Characteristics
Once the intended purpose has been established, the manufacturer must identify the characteristics relevant to classification. These include whether the device is:
- Non-invasive or invasive
- Surgically invasive or invasive through a body orifice
- Implantable or non-implantable
- Active or non-active
- Intended for transient, short-term, or long-term use
- Intended to contact specific tissues, organs, or the circulatory or central nervous systems
- Intended to administer or remove medicinal products or other substances
- Software or a device incorporating software
- A device with a specific function or technology addressed by a dedicated classification rule
Other relevant factors include the mechanism of action, energy dependence, and whether the device incorporates a medicinal substance or consists of a substance intended to be introduced into the human body.
Why this matters: These characteristics establish which classification rules must be considered under Annex VIII, Chapters I and III.
Step 3: Identify and Apply the Relevant Rules in Annex VIII
Annex VIII of the EU MDR establishes the classification rules for medical devices. The manufacturer must evaluate the rules applicable to the device's intended purpose and characteristics.
| Classification rules | Device category | Main considerations |
|---|---|---|
| Rules 1 - 4 | Non-invasive devices | Contact with the body, substances, blood, and other specific functions |
| Rules 5 - 8 | Invasive devices | Route of entry, duration of use, surgical invasiveness, and implantability |
| Rules 9 - 13 | Active devices | Therapeutic and diagnostic functions, monitoring, and administration or removal of substances |
| Rules 14 - 22 | Special categories and specific technologies | Medicinal substances, contraception, disinfection, cleaning, measurement, nanomaterials, substance-based devices, and other specifically addressed devices |
The classification rules must be interpreted in accordance with the general principles in Annex VIII, Chapter I, and the implementing provisions in Chapter II.
IVD Device Classification
IVDR classifies IVDs into four risk-based categories:
- Class A: Low individual and public health risk (e.g., laboratory equipment and specimen receptacles).
- Class B: Moderate-risk devices not covered by other classifications.
- Class C: Devices presenting a high individual risk or moderate public health risk, such as certain cancer screening and diagnostic tests.
- Class D: Devices associated with the highest individual and public health risks, including tests used to detect transmissible infectious agents in blood, tissues, or organs.
| Classification rules | Device category | Main considerations |
|---|---|---|
| Rule 1 | Class D High-Risk IVDs | Detection of transmissible agents in blood, blood components, cells, tissues, organs, or derivatives for transfusion, transplantation, or cell administration; detection of agents causing life-threatening diseases with a high or suspected high risk of propagation; and determination of infectious load in life-threatening diseases where monitoring is critical for patient management. |
| Rule 2 | Class C / Class D Blood Grouping and Tissue Typing | Blood grouping and tissue typing for immunological compatibility are Class C, except tests for specified ABO, Rhesus, Kell, Kidd, and Duffy system markers, which are Class D. |
| Rule 3 | Class C Specific Diagnostic and Screening Devices | Detection of sexually transmitted agents; infectious agents in cerebrospinal fluid or blood; infections where erroneous results may cause death or severe disability; prenatal screening; infectious or immune status determination; companion diagnostics; disease staging; cancer screening, diagnosis, or staging; human genetic testing; medicinal product monitoring; management of life-threatening diseases; and screening for congenital disorders in embryos, foetuses, and newborns under specified risk conditions. |
| Rule 4 | Class C / Class B Self-Testing and Near-Patient Testing | Self-testing devices are Class C, except pregnancy detection, fertility testing, cholesterol determination, and urine tests for glucose, erythrocytes, leucocytes, and bacteria, which are Class B. Near-patient testing devices are classified separately under the applicable classification provisions. |
| Rule 5 | Class A General Laboratory IVDs and Related Devices | General laboratory products, accessories without critical characteristics, buffer solutions, washing solutions, general culture media, histological stains intended for specific IVD procedures, instruments specifically intended for IVD procedures, and specimen receptacles. |
| Rule 6 | Class B Other IVDs | Devices not covered by the preceding classification rules |
| Rule 7 | Class B Control Materials | Control devices without an assigned quantitative or qualitative value |
What if more than one classification rule applies?
A device may fall within the scope of more than one classification rule. In such cases, the manufacturer must evaluate all applicable rules and assign the highest resulting classification.
For example, an implantable device may be subject to Rule 8, while an additional rule may apply because it incorporates a medicinal substance with an ancillary action. The manufacturer must assess both rules and apply the classification required by the applicable provisions.
Why this matters: Selecting only one rule without evaluating other potentially applicable rules can result in an incorrect classification and an inappropriate conformity assessment route.
Step 4: Assign the Final Risk Class
After evaluating the relevant classification rules, the manufacturer assigns the device to the applicable risk class.
The final classification must be justified and documented in the manufacturer's technical documentation, including the applicable Annex VIII rule and the rationale supporting its application.
Step 5: Determine the Conformity Assessment Route
The assigned risk class determines the conformity assessment procedures.
The conformity assessment route establishes the requirements for demonstrating conformity with the applicable General Safety and Performance Requirements (GSPRs), maintaining technical documentation, and obtaining CE marking.
Classification influences:
- Notified Body involvement: Whether independent conformity assessment by a designated Notified Body is required.
- Technical documentation: The scope of evidence required to demonstrate conformity with the MDR.
- Clinical evaluation: The clinical evidence needed to support the intended purpose, safety, and performance.
- Quality management system: The applicable quality management system assessment requirements.
- Post-market surveillance: The manufacturer's obligations for monitoring device safety and performance after-market placement.
- CE marking: The applicable conformity assessment procedure that must be completed before the device is placed on the market.
Certain Class I devices may be placed on the market without Notified Body involvement when the applicable conditions are met. However, Notified Body involvement is required for Class I devices with relevant special characteristics, including sterile devices, devices with a measuring function, and reusable surgical instruments, within the scope of the applicable conformity assessment requirements.
For Class IIa, Class IIb, and Class III devices, Notified Body involvement is generally required under the applicable conformity assessment procedures.
Well-Established Technologies
Well-Established Technologies (WET) refer to medical devices based on relatively simple, common, and stable designs, with limited technological evolution, well-known safety and clinical performance characteristics, and a long history of use on the European Union market. The concept is discussed in MDCG 2020-6, which provides guidance on sufficient clinical evidence for legacy devices and the assessment of well-established technologies.
Under the EU MDR, WET status can be relevant to specific conformity assessment and clinical evaluation requirements. In particular, Article 52(4) addresses the assessment of technical documentation for certain Class IIb implantable devices, while Article 61(6)(b) and Article 61(8) address exemptions from the requirement to conduct clinical investigations for specified device types.
How Does WET Affect Medical Device Classification?
WET status does not independently determine a medical device's risk class. Manufacturers must first classify the device in accordance with Article 51 and Annex VIII of Regulation (EU) 2017/745, based on its intended purpose and applicable classification rules.
Once the risk class has been established, the manufacturer should assess whether the device falls within the relevant WET provisions and whether any specific regulatory exemptions apply.
The following delegated regulations, adopted in 2026, expand the categories of devices covered by these provisions:
- Commission Delegated Regulation (EU) 2026/1359: Expands the list of certain Class IIb implantable devices exempt from the requirement for a Notified Body to assess the technical documentation of every individual device under Article 52(4).
- Commission Delegated Regulation (EU) 2026/1451: Expands the list of specified implantable and Class III devices that may be exempt from the requirement to conduct clinical investigations under Article 61(6)(b), subject to the applicable conditions.
These provisions do not constitute a general exemption from EU MDR requirements. Manufacturers must continue to meet the applicable requirements for safety, performance, clinical evaluation, risk management, and technical documentation.
What Should be Documented?
Where WET provisions are relevant, manufacturers should document the rationale for considering the device within the applicable category and assess whether the relevant regulatory conditions are met. Supporting evidence may include:
- Established design characteristics and the extent of technological evolution.
- Available clinical data and evidence of clinical performance.
- Relevant market history and post-market safety information.
- Justification for exemption, including evidence that all regulatory conditions have been satisfied.
Step 6: Document and Maintain the Classification Rationale
Classification is not complete until the decision and its justification are documented.
The manufacturer should maintain a classification rationale within the technical documentation that identifies:
- The device's intended purpose and relevant characteristics
- The applicable Annex VIII classification rule or rules
- The specific provisions supporting the classification decision
- The assessment of multiple applicable rules, where relevant
- The final assigned risk class
- The rationale for the selected conformity assessment route
The classification should be reviewed whenever changes to the intended purpose, design, operating principle, duration of use, or other relevant characteristics could affect the applicability of the classification rules.
MEDREG provide regulatory services to help determine the appropriate risk classification of devices in accordance with EU Regulations.
