From MDD to MDR
We stand ready for MDR compliance at Imsons Med-Technik.
The Medical Device Directive (MDD), which had been in place since 2002, was replaced across the European Union by the EU Medical Device Regulation (MDR). In response, Imsons Med-Technik is fully prepared for MDR. Since July 2021, an MDR transition programme has been in place within the organisation to ensure full compliance with the updated regulations.
We are working to obtain EU-MDR certification for all classes of medical devices, to ensure our instruments remain available across every market. Class I devices are the first milestone, with an ongoing transition process for the Class IIa and IIb classifications.
We stand ready for MDR compliance at Imsons Med-Technik.
With the Medical Device Regulation now in force, we have taken proactive measures to align with the changes. The anticipated impact of these regulations is particularly significant for Class IIa medical devices, which include invasive and electrical devices. Our preparedness establishes us as a dependable partner in navigating this evolving regulatory landscape, and we are well-equipped to address the implications for Class IIa devices, particularly within the invasive and electrical device categories.
We stand ready for MDR compliance at Imsons Med-Technik.
Commitment to quality and compliance
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 optimising costs.
Imsons Med-Technik's approach to regulatory adaptation
Acknowledging the 2017 announcement by the European Commission regarding the implementation of a Single Regulatory Document (SRD) for all Class IIa devices, we recognise the necessity of preparing for this regulatory framework.
Annex VIII
Classification of MDR medical devices
Where a device sits decides the conformity route, and how much evidence has to sit behind it. The classes below are the ones a buyer in this trade is most likely to be placing their own product against.
| 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. Imsons Med-Technik 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. | 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. |
Summarised for orientation only. Classification for your own device is determined by the regulation and your notified body, not by this page.
In closing
Conclusion
At Imsons Med-Technik, we use up-to-date 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 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.
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