Class I medical devices under the EU MDR are considered low-risk devices. These medical devices are usually non-invasive and for transient use, such as hospital beds or bandages, or invasive tools used only transiently in body orifices, such as dental impression materials.
Class I devices can be active, such as examination lamps.
However, the MDCG 2021–24 Guidance on the classification of medical devices specifies three subclasses of Class I devices based on device-specific features, that do require assessment by a Notified Body.
Class I medical devices are subdivided:
- Class Ir (Reusable Surgical Instruments): are instruments designed for multiple use after proper cleaning and sterilization procedures. A notified body must assess the device’s reuse, including cleaning, disinfection, sterilization, maintenance, functional testing, and related usage instructions.
- Class Im (Devices with a measuring function): Any Class I device with a measuring function must provide accurate measurement results. A notified body is required to assess aspects relating to the metrological requirements. Examples include expansion thermometers and measuring cups
- Class Is (Devices in sterile condition): These devices are sold and delivered in sterile condition. A notified body is required to assess the aspects relating to establishing, securing and maintaining the sterile condition. An Example would be sterile bandage or a sterile syringe.
Clinical Evaluation for Class I Medical devices
Manufacturers of Class I devices do not normally need to submit CERs to a notified body for assessment.
However, a Class I device is still subject to the MDR requirements to perform a Clinical Evaluation in that it must demonstrate conformity with the Annex I GSPRs, suitability for the intended purpose and an acceptable benefit-risk profile.
Therefore, a Clinical Evaluation Report is still required for Class I devices and should be written with a similar degree of care and skill to those required for higher-risk devices.
Furthermore, Class I devices that are supplied sterile (Class Is), or reusable (Class Ir) or measuring function (Class Im) will require the involvement of a notified body. Manufacturers of these types of devices should prepare CERs with notified body involvement on mind.
Clinical Evaluation of Class I Reusable Surgical Devices
The following information needs to be given importance in the clinical evaluation of reusable Surgical Class I devices:
~ Durability and Material Integrity: The clinical evaluation concerning reusable Class I devices covers material integrity and durability, so the device can withstand multiple cycles of sterilization, cleaning, and disinfection without compromising performance or structural integrity.
~ Sterilization Validation: A rigorous process for sterilization should maintain the sterility of the device during its use; hence, the clinical evaluation will also involve data on the process of sterilization validation, and the ability of the device to remain sterile after multipurpose.
During the clinical evaluation, these are coming under the preclinical data that was retrieved from the manufacturer.
~ Risk management: The clinical evaluation should incorporate risk management strategies to prevent device reuse, such as preventing infection vectors from improper cleaning or sterilization and ensuring wear and tear do not compromise the device’s function or safety
Clinical Evaluation of Class I Measuring Device
The following information needs to be given importance in the clinical evaluation of Class I measuring devices:
~ Accuracy Testing: The device must undergo clinical testing to ensure accurate measurements compared to established standards, demonstrating its ability to deliver precise and reliable measurements across various conditions, demonstrating its reliability.
During the clinical evaluation, this is captured from the preclinical performance test evaluation that was retrieved from the manufacturer.
~ Performance Consistency: It is essential that the device performs consistently over time. The device’s long-term stability and performance across various user groups and environments must be consistently assessed in clinical evaluations.
~ User Training and Usability: The clinical evaluation should evaluate the user interface and the effectiveness of user training for accurate use of measuring devices, ensuring ease of use for healthcare professionals and patients.
Clinical Evaluation of Class I Sterile Devices
The following information needs to be given importance in the clinical evaluation of Class I sterile devices:
~ Sterilization Validation: The clinical evaluation comprises documentation on the sterilization method utilized, such as autoclaving, radiation, or gas sterilization that complies with international sterilization standards, which is effective in eliminating microorganisms.
~ Packaging Integrity: Packaging of sterile devices becomes an important factor in maintaining sterility, and clinical evaluations should also encompass tests concerning materials and design that provide maximum protection of the device against contamination.
~ Infection Control: Clinical data should show the device’s safety record, including infection rates, adverse events, and complications, indicating its intended use does not cause infections or complications.
Shelf Life: Testing long-term stability where the device’s performance and functionality are checked after regular intervals up to its shelf life. These are generally done by storing the device under conditions specified like ambient temperature and humidity for extended periods.
POST-MARKET SURVEILLANCE
Manufacturers of Class I devices need to EU MDR article 83 to perform PMS activity. This involves creating a detailed plan and reporting the results. The report should be updated whenever necessary and must be readily available to provide to the competent authorities upon request.
CONCLUSION
The Class I medical devices according to the EU MDR have a low level of risk devices, but they still require an evaluation by a Notified Body. Class I devices have three subclasses: Class I Reusable Surgical Devices, Class I measuring Devices, and Class I sterile Devices.
Continuous revision of a Clinical Evaluation Report (CER) is very important because it pursues constant demonstrating of safety and performance through clinical evidence during the whole life of a device.
Manufacturers must also plan, establish, document, implement, maintain, and update a post-market surveillance system proportionate to the risk class and appropriate for the device type
Author
Dr Minu Lazar, BDS (Junior Consultant CER)
REFERENCE
1. (EU) 2017/745 (MDR)
2. MEDDEV 2.7/7 revision 4, clinical evaluation: a guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EE
3. Ethen Drower, Breaking Down EU MDR Implementation for Class 1 Medical Devices
4. EUMDR-2023
5. “Clinical Evaluation of Medical Devices: A Practical Guide” by Joseph A. Buckley
6. “Post-market Surveillance of Medical Devices: A Global Overview” by Peter L. H. Lee
