KUMMAS Corporation

Medical Device Regulations

As of 2017, the Medical Device Directive (MDD), which has been in place since 2002, has been repealed by the EU Medical Device Regulation, which will ultimately replace it in 2024. As a result, it is fortunate that Kummas Corporation is prepared to make this switchover to the MDR as soon as it becomes effective. An MDR transition program has been in place within the organisation since July 2021 to ensure compliance with the MDR regulations. Kummas Corporation will become EMDR-certified within the next year for all classes of medical devices to remain on the market even after 2024 when it takes effect. Fortunately, Kummas Corporation will conform to MDR regulations in July 2022 for class I medical devices. A transition is in progress between classes Iia and Iib.

We stand ready for MDR compliance at kummas Corporation.

With the upcoming 2024 implementation of the new Medical Device Regulation (MDR), we have taken proactive measures to align with the impending changes. The anticipated impact of these regulations is especially significant for Class IIa medical devices, encompassing categories such as invasive and electrical devices.

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.

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.

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.

Conclusion

We at Kummas Instruments use the latest technology to make our products as efficient and effective as possible. Our products are used in hospitals, clinics, and other healthcare facilities worldwide. We are aware of the importance that the healthcare industry places on access to high-quality instruments at an affordable price so that providers can provide the best possible care to their patients. Our compliance team at Kummas Instruments is ready to assist you with your requirements.