Dear hospital network managers,

Let me start with a conclusion: a silex wireless bridge can be a great solution to provide a wireless connectivity to your existing medical device. And it is a cost-efficient and time saving solution.

When looking to bring Wi-Fi connectivity to medical devices of your hospital, and you might ask yourself about the regulatory implications, especially concerning the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).

Let's clarify some key points.

Understanding MDR and IVDR

The European Union has a strict regulatory framework for medical devices and in vitro diagnostic medical devices to ensure their safety, quality, and performance.

The Medical Device Regulation (MDR - Regulation (EU) 2017/745) governs instruments, apparatus, software, implants, and other articles intended for specific medical purposes on human beings, as well as their accessories. Its core objective is to ensure the smooth functioning of the internal market for these devices while maintaining a high level of protection for patients and users' health and safety.

Similarly, the In Vitro Diagnostic Medical Device Regulation (IVDR - Regulation (EU) 2017/746) regulates devices like reagents, instruments, and software intended for in vitro examination of human specimens, such as blood and tissue donations, to provide diagnostic information. The IVDR also aims for a well-functioning internal market and high standards of quality and safety for its specific product category. Both regulations fundamentally revised previous directives to establish more robust, transparent, predictable, and sustainable frameworks, ensuring a high level of safety and health.

These regulations help manufacturers to provide hospitals with safe medical devices.

Potential Costs of Medical Device Recertification for a Wi-Fi Module Update

If your medical device's manufacturer were to update its existing Wi-Fi module or integrate one directly into the device, this would typically be considered a modification to the device's design or characteristics. Such a change could necessitate a recertification process under the MDR, which involves significant time and cost for the manufacturer. Based on the provided fee list for conformity assessment activities under the MDR, the costs for administrative fee, technical documentation and its assessment, expert panel consultation for high-risk devices (Class III, for example), and so forth.

This cost could add up to a five-digit figure.

And that is accompanied by another important factor.

Time.

A Wi-Fi module upgrade or replacement takes time. Request an original manufacturer. Wait time for the arrival of their technician. Operational days of medical devices get less and less, and in the worst case, the medical device cannot be used when it is needed to treat patients.

Why a Silex Wireless Bridge Doesn't Pose MDR Regulatory Issues

 Here's where the Silex wireless bridge offers a solution.

An independent assessment by QARA Associates Ltd. determined that the Silex BR-500AC Wireless Bridge is not a medical device or an accessory to a medical device under the MDR.

The key factor in this determination is the intended use of the product, as defined by its manufacturer. The Silex BR-500AC (or BR-330AC-LP) is designed to convert a non-wireless device (like a medical device with an ethernet port) into a wireless one, connecting it to a Wi-Fi network.

Crucially, the Silex BR-500AC itself does not perform any specific medical purpose included in the MDR's definition of a medical device. It simply provides network connectivity.

Furthermore, it is not considered an "accessory" subject to the MDR regulation because it doesn't specifically enable the medical device to perform its intended purpose, nor does it directly assist the medical device's medical functionality. The medical device achieves its medical purpose regardless of whether it's connected via an ethernet cable or the Silex wireless bridge.

Therefore, when purchased and used as a standalone product under the Silex brand to provide Wi-Fi connectivity to your existing medical devices, the Silex BR-500AC Wireless Bridge does not fall under the scope of the MDR. The Silex bridge is a general-purpose network device, just like an Ethernet cable, its intended purpose is to provide a network connection, not a medical function.

(In case you work for a medical device manufacturer considering to equip your medical device with our wireless bridge or Wi-Fi module, there’s another consideration to give. Depending on a use case and its requirement, the required regulation varies. Please contact our sales teams for further information)

Conclusion: Saving Time and Money with a Silex Bridge

 By utilizing an external Silex wireless bridge to provide Wi-Fi connectivity to your medical devices, you can avoid the significant regulatory burdens, costs, and delays associated with modifying and potentially recertifying your existing medical devices under the MDR.

You don't need to wait for your medical device manufacturer to go through an expensive and lengthy recertification process for an integrated Wi-Fi module.

You bypass the substantial financial costs that would be incurred for technical documentation assessments, change assessments, and potential expert consultations if the original medical device were to be modified.

In essence, a Silex bridge acts as a network adapter, not a medical component. This offers a faster and more cost-effective way to bring wireless capabilities to your medical equipment without triggering complex medical device regulatory requirements for the existing devices themselves.

When it absolutely must connect, Silex is here to provide a solution.

References

Regulation (EU) 2017/745

Regulation - 2017/746 - EN - Medical Device Regulation - EUR-Lex

Legal disclaimer

The information is provided in good faith, however, we make no representation or warranty of any kind, express or implied, regarding the accuracy, adequacy, validity, reliability, availability or completeness of any information in this post by Silex Technology or QARA Associates . In case of doubts for your specific case, please consult with legal and regulation experts.