View allMDR
As of 2017, the Medical Device Directive (MDD), which has been in place since 2002, has been repealed by the EU Medical Device Regulation, which will ultimately replace it in 2024.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 QEQI Enterprises is prepared to make this switchover to the MDR as soon as it becomes effective. An MDR transition programme has been in place within the organisation since July 2021 to ensure compliance with the MDR regulations. QEQI Enterprises will become EMDR-certified within the next year for all classes of medical devices in order to remain on the market even after 2024 when it takes effect. Fortunately, QEQI Enterprises will conform to MDR regulations in July 2022 for class I medical devices. A transition is in progress between classes IIa and IIb.
Our company has taken full advantage of the additional grace period at our disposal. Upon successful audit by SGS Belgium our ISO 13485 was recently renewed. Our products are prepared adequately to maintain excellent data integrity criteria and limit the expenses associated with hasty deployments by utilising this additional grace period.
We are MDR-Ready at QEQI Enterprises
There will be a new Medical Device Regulation (MDR) in 2024, and QEQI Enterprises is ready to meet these regulations. It is expected that these new regulations will have an impact on Class IIa medical devices, such as invasive and electrical devices.
There will be a new Medical Device Regulation (MDR) in 2024, and QEQI Enterprises is ready to meet these regulations. It is expected that these new regulations will have an impact on Class IIa medical devices, such as invasive and electrical devices.
As a company that is well-positioned to help you navigate the new Medical Device Regulations (MDR) products, QEQI Enterprises is a perfect choice. The quality management systems we have in place are ready for MDR compliance. We have years of experience developing and manufacturing devices that comply with Annex II, III, and IV requirements of 93/42/EC.
Since we provide surgical instruments to the medical community, we are prepared for these changes to take effect so we can continue providing them with high-quality products. Our products are all designed, developed, and manufactured with a unique combination of expertise that provides you with a wide range of flexibility in today’s ever-changing global market environment. We will continue collaborating closely with our partners in this challenging economic climate to bring innovative solutions that improve compliance and lower costs.
QEQI Enterprises
QEQI Enterprises is ready for the changes coming to Class IIa medical devices. Considering that the European Commission (EC) already announced in 2017 that it would implement a Single Regulatory Document (SRD) for all Class IIa devices, it is time to prepare for this new regulatory framework.
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 QEQI Enterprises is prepared to make this switchover to the MDR as soon as it becomes effective. An MDR transition programme has been in place within the organisation since July 2021 to ensure compliance with the MDR regulations. QEQI Enterprises will become EMDR-certified within the next year for all classes of medical devices in order to remain on the market even after 2024 when it takes effect. Fortunately, QEQI Enterprises will conform to MDR regulations in July 2022 for class I medical devices. A transition is in progress between classes IIa and IIb.
Classification of MDR medical Devices
| Class | Examples of Devices | Description |
|---|---|---|
| Class I | 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. Wrangler 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. |
| Class III | Surgical mesh, replacement heart valves, breast implants, pacemakers, and other continuously monitored devices. | Class III devices are the highest-risk category and undergo the most stringent regulatory control. These devices undergo extensive clinical testing and evaluation before being approved for use. |