As of 2017, the Medical Device Directive (MDD), which has been in place since 2002, has been repealed by the EU Medical Device Regulation, which will ultimately replace it in 2024.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 Wrangler Surgical Instruments 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. Wrangler Instruments 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, Wrangler instruments 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 Wrangler Instruments.
There will be a new Medical Device Regulation (MDR) in 2024, and Wrangler Instruments 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, Wrangler Instruments 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.
Wrangler Instruments 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.
The SRD will replace Annex III and IV requirements of 93/42/EC with one document. The EC also announced its intention to increase transparency by allowing manufacturers to publish their data on CE-marked products. In addition, it has been stated that manufacturers will have their own dedicated validation toolkit, which includes a reference document template and a datasheet template, showing how they can present their data within those documents.
Classification of MDR medical devices
There are four classes of medical devices that are classified under the MDR:
- Class I
- Class IIa
- Class IIb
- Class III
Class I
Bandages, stethoscopes, eyeglasses, and other medical devices used to treat patients would be classified under this category. With help from UDI Codes and ISO ISO 15223-1 labels, Wrangler Instruments offers complete product identification and traceability. The following are three other subclassifications of Class I medical devices that can be categorised:
- Is – a sterile condition
- Im – measuring function
- Ir – reusable surgical.
Class IIa
In this category, you will find hearing aids, catheters, and short-term contact lenses used for medical purposes.
Class IIb
These products include forceps, scissors, scalpels, ventilators, insulin pens, long-term contact lenses, incubators, and forceps are just a few of the items that fall into this category.
Class III
Class III devices are at the bottom of the list of medical devices. These devices include the surgical mesh, replacement heart valves, breast implants, pacemakers, and other devices that need to be monitored continuously, such as surgical mesh and pacemakers.
Conclusion
We at Wrangler 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 Wrangler Instruments is ready to assist you with your requirements.
As you navigate the complexity of these new requirements, make sure to reach out to our sales team for assistance and for insight into the MDR certification development timeline.
