How to Classify Your Medical Device Under the EU MDR and IVDR
If you currently market and sell medical devices in the European Economic Area (EEA) or are planning to do so soon, products must be certified under the new European Union (EU) Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR) to maintain/obtain a CE marking. Under these new regulations, the definitions of medical and in vitro diagnostic devices have been expanded. Additionally, certain devices have been reclassified to higher or new risk categories. For example, spinal implants that were previously categorized as Class IIb are now categorized as Class III devices under the EU MDR.
A critical step in certifying your device is to ensure that it is assigned the correct classification. This will help you identify product requirements early in the development phase and establish a roadmap for compliance throughout the entire lifecycle. It also helps you estimate the costs and timeframe associated with getting your product to market.
In this article, we take a closer look at the classification criteria set forth by the EU MDR and IVDR and provide steps for assigning the right classification to your device. We also explore how a product-centric quality management system (QMS) can help you effectively manage and track all the technical and clinical information associated with the various device classifications and streamline compliance.
EU MDR CLASSIFICATION CRITERIA
The EU MDR categorizes medical devices as either Class I, Class IIa, Class IIb, or Class III. This classification is based on the risk that the device poses to patient safety as well as the following factors:
- How long the device is in contact with the patient/user (i.e., duration of use)
- Transient duration devices are used continuously for less than one hour
- Short-term duration devices are used continuously between one hour and 30 days
- Long-term duration devices are used continuously for more than 30 days
- Whether the device is invasive or noninvasive
- Invasive devices enter the body through an opening or surface of the body
- Noninvasive devices do not enter the body
- Whether the device is active or nonactive
- Active devices require a source of energy to operate
- Nonactive devices do not require a source of energy for operation
Class I devices are mostly noninvasive and pose a low risk to patients. Approximately 70% of medical devices in the EU market fall into this category, and are further divided into the following subclasses:
- Class I: Non-sterile or have no measuring function (e.g., wheelchair, hospital bed)
- Class Is: Delivered sterile; must be either transported in a sterile condition or sterilized upon receipt (e.g., sterile gauze, personal protection kits)
- Class Im: Include a measuring function (e.g., stethoscope, thermometer)
- Class Ir: Reprocessed or reused (e.g., surgical instrument, endoscope)
Class IIa devices pose a medium risk to patients. They are typically invasive and installed in the body for less than 30 days. An estimated 20% of medical devices in the EU market fall into this category. Examples include hearing aids, ultrasonic diagnostic equipment, and catheters.
Class IIb devices pose a medium to high risk to patients. They are mostly invasive and usually installed in the body for more than 30 days. Approximately 8% of medical devices fall into this category. Examples include infusion pumps, ventilators, and dialysis machines.
Class III devices pose a high risk to patients. They are invasive and designed to either support human life or prevent the impairment of human health. Only 2% of medical devices fall into this category. Examples include pacemakers and prosthetic heart valves.
The classifications above determine the route by which a medical device obtains its CE Mark. The conformity assessment routes are defined in Annexes IX, X, and XI of the EU MDR.
Effective May 26, 2021, new medical devices should have been certified under the EU MDR. The European Commission recently issued Regulation (EU) 2023/607, which extends the transition period for devices that were certified under the EU’s previous Medical Device Directive (MDD) or Active Implantable Medical Device Directive (AIMDD) as follows:
- Class III and Class IIb implantable devices (except for sutures, staples, and certain dental devices): December 31, 2027
- Class IIa and Class IIb devices not covered above, Class Is, and Class Im devices: December 31, 2028
- Devices with a declaration of conformity dated prior to March 26, 2021: December 31, 2028
DIFFERENCE BETWEEN EU MDR AND FDA MEDICAL DEVICE CLASSIFICATIONS
Although the EU MDR and U.S. Food and Drug Administration (FDA) use similar nomenclature for classifying medical devices, there are some key differences to keep in mind.
The EU MDR applies a rule-based system, which separates medical devices into four different classes (i.e., Class I, IIa, IIb, and III) and three risk-based categories (i.e., duration of use, invasive/noninvasive, and active/nonactive). The risk level of the device will determine the extensiveness of the quality management system (QMS) as well as the amount of clinical data that needs to be gathered.
In contrast, the FDA uses a three-tier classification structure for medical devices (i.e., Class I, II, and III). These classifications are based on the device’s intended use, indications for use, and the risk that it poses. Each class is assigned various regulatory controls to ensure the safety and effectiveness of the device. These controls include premarket approval (PMA) and postmarket surveillance. Most devices in the U.S. are classified by identifying similar (i.e., predicate) devices that are already cleared by the FDA.
EU IVDR CLASSIFICATION CRITERIA
The EU IVDR has established a new risk-based classification system for in vitro diagnostic devices. They are now categorized as Class A, B, C, or D.
Class A devices pose a low risk to both individuals and public health. They include laboratory devices and instruments.
Class B devices pose a moderate risk to individuals and a low risk to public health. Examples include self-testing devices to detect pregnancy, glucose, and cholesterol levels.
Class C devices pose a high risk to individuals and a moderate risk to public health. They include devices used for cancer and genetic testing.
Class D devices pose a high risk to both individuals and public health. They include devices used for blood screening and the detection of high-risk diseases.
These classifications determine the route by which an in vitro diagnostic device obtains its CE Mark. The conformity assessment routes are defined in Annexes IX, X, and XI of the IVDR.
Effective May 26, 2022, new in vitro diagnostic devices should have been certified under the EU IVDR. Devices that were placed on the EU market prior to May 26, 2022, and certified under the EU’s previous In Vitro Diagnostic Medical Device Directive (IVDD) must comply with the new IVDR by May 26, 2025.
Per the European Commission’s recently adopted Regulation (EU) 2023/607, an extension period has been granted for devices that were previously self-declared (i.e., no notified body involvement) under the IVDD as follows:
• Class D devices: May 26, 2025
• Class C devices: May 26, 2026
• Class B and Class A sterile devices: May 26, 2027
STEPS FOR CLASSIFYING YOUR MEDICAL DEVICE UNDER THE EUROPEAN REGULATIONS
1. Develop and document the following statements:
- General description of the device that includes its intended purpose and use
- Target patient population and medical conditions to be monitored, treated, and/or diagnosed
- Principles of operation and mode of action for the device
These statements should be included in the product’s technical documentation.
2. Review Annex VIII of the EU MDR or IVDR to obtain device classification rules.
Annex VIII provides definitions that are specific to the classification rules (e.g., duration, active, invasive) and outlines how the different rules should be implemented based on the intended use of the device. The MDR provides 22 classification rules for medical devices, whereas the IVDR provides seven classification rules for in vitro diagnostic devices.
3. Refer to guidance documents published by the Medical Device Coordination Group (MDCG).
- MDCG 2021-24 Guidance on Classification of Medical Devices
- MDCG 2020-16 rev. 2 Guidance on Classification Rules for In Vitro Diagnostic Medical Devices Under Regulation (EU) 2017/746
These documents provide in-depth explanations of the MDR and IVDR rules. They consider device characteristics such as degree of invasiveness, potential toxicity, and parts of the body that are affected. The MDCG documents also present practical examples of how the rules would apply to various devices.
4. Determine the risk class that is applicable to your device based on the rules and supporting MDCG guidance documents.
Under the new IVDR, most devices will be categorized as either Class B or C; however, if several classification rules apply to a particular device, the higher classification should be applied.
Once you’ve classified the device, include your decision and supporting rationale in the technical documentation.
SIMPLIFYING MDR AND IVDR COMPLIANCE WITH A PRODUCT-CENTRIC QMS
To ensure the safety, quality, and efficacy of medical devices throughout their entire lifecycle, manufacturers must have an effective QMS in place. The EU MDR and IVDR outline specific resources, processes, and product information that are needed to support a QMS and demonstrate compliance. Your device classification will help you establish proper design controls, performance data, and other critical QMS documentation early on so that the certification process runs smoothly.
Having a robust QMS at your disposal makes it easier to maintain and retrieve the vast quantity of documentation, processes, and records that may be requested by a notified body as part of their regulatory assessment. By automatically linking technical documentation and quality processes like corrective and preventive actions (CAPAs) directly to the product bill of materials (BOM), a product-centric QMS enables you to better manage and track changes throughout the development process to ensure your product information is always audit-ready and further streamline MDR and IVDR compliance.