We Stand Ready for MDR Compliance at Longstone
As of 2017, the Medical Device Directive (MDD), which had been in place since 2002, was repealed by the EU Medical Device Regulation (MDR), set to be fully implemented in 2024. In response, Longstone is fully prepared to transition to MDR as soon as it takes effect. Since July 2021, an MDR transition program has been in place within the organization to ensure full compliance with the updated regulations. Longstone will obtain EMDR certification within the next year for all classes of medical devices, ensuring continued market availability beyond 2024. Notably, compliance for Class I medical devices will be achieved by July 2022, with an ongoing transition process for Class IIa and IIb classifications.


We Stand Ready for MDR Compliance at Longstone
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 particularly significant for Class IIa medical devices, which include invasive and electrical devices. Our preparedness for the forthcoming 2024 Medical Device Regulation (MDR) establishes us as a dependable partner in navigating this evolving regulatory landscape. We are well-equipped to address the implications for Class IIa medical devices, particularly within the invasive and electrical device categories.
We Stand Ready for MDR Compliance at Longstone
As a supplier of surgical instruments to the medical industry, we have fully embraced these regulatory updates to ensure a consistent supply of high-quality products. Our extensive portfolio, developed through a unique combination of expertise and innovation, provides the flexibility needed in today’s ever-changing global market. Despite economic challenges, we remain committed to collaborating with our partners to develop innovative solutions that enhance compliance while optimizing 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 of preparing for this upcoming 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
At Longstone, we utilize cutting-edge technology to manufacture products that are both highly efficient and effective. Our instruments are trusted by hospitals, clinics, and healthcare facilities worldwide. We understand the critical importance of providing healthcare professionals with access to top-tier instruments at competitive prices, ensuring the highest standard of patient care. Our dedicated compliance team stands ready to support you with all regulatory requirements.