EU MDR 2017/745 has a strong classification system, which ensures safety and efficacy of medical devices.
Manufacturers are responsible for applying for certification, determining the appropriate classification of their product, and selecting the conformity assessment route as required by regulations.
Based on the assigned classification, the larger risk devices are imposed with stricter regulations. Medical Device Classification can be based on intended purpose, characteristics of the item, or kind of risk involved concerning patient and user risk.
Criteria for Classification:
Medical devices have been categorized into four classes as Class I, Class IIa, Class IIb, and Class III. Total of 22 rules are included in EU MDR for classification of medical devices.
The classification rules are set out in Annex VIII of the regulation and are determined as follow:
Duration of Use:
· Transient (< 60 minutes)
· Short-term (> 60 minutes and < 30 days)
· Long-term (> 30 days)
Invasiveness:
· Non-invasive devices
· Invasive devices
· Surgically invasive devices
Active and Non-Active Devices:
· Active devices rely on an energy source for operation.
· Non-active devices do not rely on an energy source.
Special Rules for Specific Device Categories: Including software, diagnostic devices, and implantable devices.
Classifications of devices:
- Class I (Low Risk): The devices in this category bear very minimal risk to both users and patients. Most Class I devices, except those that are sterile, have a measuring function, or are reusable surgical instruments do not require Notified Body intervention for any type of support.
- Class IIa (Medium Risk): These devices have a moderate risk and require Notified Body involvement in the conformity assessment process.
- Class IIb (Higher Risk): Devices in this class have higher risks and necessitate comprehensive conformity assessments. They include devices that administer or remove medicinal products or therapeutic substances.
- Class III (Highest Risk): This classification covers devices with the highest risk and complexity, requiring the most stringent regulatory controls. Class III devices typically support or sustain life, prevent life-threatening conditions, or present a significant risk to patients and users.
Considerations for Medical Device Software
Under the MDR, the software is classified according to its expected purpose and risk profile.
For example, a particular type of software can be classified anywhere from class I to class III depending on the functionality of a particular software like diagnostic imaging software or a mobile application that monitors health conditions.
This rule 11 in Annex VIII of the MDR explicitly addresses software and emphasizes its importance in the modern medical technological scenario.
Role of the Manufacturer in Classification
Role of the Manufacturer in Classification
Manufacturers hold the responsibility for correctly classifying their medical devices. The steps to be taken are mentioned below:
- Reviewing the classification rules in Annex VIII.
- Identifying the intended purpose of the device.
- Determining all possible risks associated with the device’s use.
Challenges in Classification
The EU MDR has introduced stricter and more specific rules, making classification a complex process. Common challenges include:
1. The misinterpretation of its intended purpose leads to an erroneous classification.
2. Devices which exist on the borderline of different regulatory frameworks (for instance-as in the case of medical devices and cosmetics) can cause ambiguity.
3. Regulation of Software: The relevance of the software to the scope of normal operation creates a continuous challenge in classifying.
Steps for Accurate Classification
For this, manufacturers should follow these steps:
1. Familiarize with the 22 classification rules and their sub-rules.
2. Seek guidance from experienced regulatory professionals for compliance.
3. Seek guidance on classification from Notified Bodies during the design and development stages.
4. Document thoroughly the reason for classification together with any consultations occurred.
Conclusion
The EU MDR classification system has laid down an essential foundation for the purpose of ensuring safety and effectiveness of medical devices within the EU market.
The classification framework, which categorizes devices based on intended use, risk profile, and technical complexity, is a standard approach in compliance to regulatory provisions.
It also led to identification of the proper conformity assessment procedures by manufacturers as it stays in the protection of public health by ensuring high standards of quality and safety in place.
Author
Shristi Ahir
Sr. Consultant, EU MDR Technical Expert|Medical Device