MDR Compliance at Med Miles.

Med Miles
Acknowledging the 2017 announcement by the European Commission (EC) regarding the implementation of a Single Regulatory Document (SRD) for all Class IIa devices, we recognize the necessity to prepare for this imminent regulatory framework.
Surgical Instruments
Our readiness for the forthcoming 2024 Medical Device Regulation (MDR) positions us as a reliable partner in navigating through the evolving landscape. We are well-prepared to address the implications on Class IIa medical devices, particularly those falling under the categories of invasive and electrical devices.
In light of our role as suppliers of surgical instruments to the medical community, we have embraced these regulatory changes to ensure a continuous supply of top-notch products. Our diverse portfolio, born from a distinctive blend of expertise, provides you with the flexibility needed in today’s dynamic global market. Despite the challenging economic climate, our commitment remains unwavering as we closely collaborate with partners to deliver innovative solutions that enhance compliance and reduce costs.

Classification of MDR medical Devices
Class | Examples of Devices | Description |
---|---|---|
Class 1 | Bandages, stethoscopes, eyeglasses, and other medical devices used to treat patients. | Class I devices are considered low-risk and are subject to general controls. They are non-invasive and do not pose a significant risk to patients. Kummas Instruments ensures complete product identification and traceability through UDI Codes and ISO 15223-1 labels. |
Subclassifications: Is (sterile condition), Im (measuring function), Ir (reusable surgical) | Subclassifications within Class I further categorize devices based on specific characteristics such as sterility, measuring function, and reusability. | |
Class IIA | Hearing aids, catheters, short-term contact lenses. | Class IIA devices are of moderate risk and require a higher level of regulation compared to Class I. |
Class IIB | Forceps, scissors, scalpels, ventilators, insulin pens, long-term contact lenses, incubators, forceps. | Class IIB devices pose a higher level of risk than Class I and IIA devices. They require a more rigorous assessment and conformity assessment procedure. |