Wireless Compliance for Medical Device Manufacturers: Overview of Radio Frequency Module Integration

As a medical manufacturer, you may be adding a wireless component to your device for the first time. Perhaps you have an existing model, and you are excited to finally ditch the cords. Even if you have used wireless technology for years, you may need new capabilities or a new radio frequency (RF) module supplier. In each of these scenarios, you should apply similar guidelines to streamline your international compliance efforts.  

In this article, we will focus on global wireless compliance for medical device manufacturers who may not have experience with global wireless requirements. More specifically, we will discuss what to consider if you intend to certify your device internationally with an integrated third-party module.  

Selecting wireless module suppliers and modules

Once your team has developed a list of potential countries to enter, you can begin to understand the compliance efforts needed for each country. This will dictate what you need for the third-party module manufacturer. If, for example, you intend to sell the wireless version of your device only in the United States, there are fewer compliance hurdles. It is safe to say that most RF modules will have Federal Communications Commission (FCC) certification. If you are considering a global launch — including major markets in Asia, South America, Africa, and Europe — there is more to consider.

Start by asking potential module suppliers where their units are certified early in the supplier selection process, as this can help you choose. For example, you are integrating Bluetooth (BT) into your medical device and have the choice between two BT module manufacturers, one with approvals in several countries and another with none. The supplier with existing approvals can be an advantageous choice, especially if approvals exist in markets where you plan to distribute your wireless device.

Next, you should confirm the module meets specifications in the countries you intend to enter. This isn’t usually an issue because many technologies and frequencies are harmonized. For example, the ISM (industrial, scientific, and medical) bands for Bluetooth are almost universal. You may also be able to adjust the frequency of your module to meet country specifications. Cellular modems typically can fit a country’s spectrum. However, one must consider it early in the module selection and integration process, as there are instances where the RF module may be incompatible with national wireless regulations. The frequency could be unavailable or allocated to a different purpose. They may stipulate an output power level that is too low for your intended use. You could be using the wrong modulation or channel bandwidth.  

Out of dozens in a global product launch, only one or two countries may have technical legislation preventing certification. A manufacturer may choose not to sell the wireless version of its medical device in these countries. They may look for an entirely different module if these are important markets. Too often a salesperson will find an opportunity in a new market, typically a positive development for any manufacturer, only to learn the product cannot be used in that country under its existing specifications. The key, as always, is to know early. An open dialogue with the module manufacturer can also be helpful. Ask if they sell other models in the market where the primary model is restricted. Check what their other customers have done, if anything, for a substitute.

Modular vs. System-level wireless certifications

International certifications for all wireless devices, including medical devices, are often discussed in terms of modular vs. system-level approval. At its most basic, the thinking is as follows: if I want to sell in a specific country, do I have to approve my end unit, a medical device, with the wireless authority? Or can I approve only the Bluetooth module integrated into the device, purchased from a third party?

If the latter is the case, then you would ask: if I’ve approved the BT module, are all my medical devices that use the module now compliant? We have several versions of our units. Since they use the same module and the country only requires approval of the module, in effect we approved them all, right? Therefore, if my BT supplier already has wireless approval, my work is done?

This line of thinking will help frame your strategy towards wireless compliance, but the details and idiosyncrasies of various markets complicate the picture. The goal is to understand the following: how will our RF module’s regulatory certifications impact our compliance efforts?

Although a good starting point, asking if a country allows modular or system-level approval risks oversimplifying the compliance roadmap. A test lab can send you to their international approvals group. You can ask a project manager to confirm wireless certification in your target market. However, it‘s important to ask more questions, such as: Do you have a copy of the country’s law stating this? Do we still need to register our company or brand name with the wireless authority since the approval for the module is in another company’s name? Does our importer need to be on the certificate? What about the labeling? Do we need permission to use the certificate from the module manufacturer? Does the medical application of the device restrict or impact the RF/Wireless application, e.g., are there restrictions on sending medical data?

While a certified RF module may not always be sufficient, it often helps. There are instances where the government telecommunications approval body will need to evaluate the EMC and safety aspects of your medical device. Once they see you are using an approved integrated RF module, they may wave RF testing requirements, saving cost and effort. You may still need to certify your medical device with the “ministry of communications” and could even need to test to EMC/safety standards. It may not feel like it, but you have still reduced your workload by choosing a certified module.  

Documentation needed from the RF module supplier

The required documents from the RF module supplier will depend on the destination countries. There are, however, some standard items you will need if you are seeking wireless compliance on multiple continents:

• The module’s test reports to European (and/or FCC) RF/EMC and Safety standards. It is important to note early in the process that these reports were recently issued to current standards.  

• Basic documents such as user manuals, possibly translated to official languages in your target markets, and data sheets.  

• Some countries will require authorization from the RF module manufacturer. This can be a statement that your medical device can use the RF test reports as part of your application for wireless compliance (or something similar). Some RF suppliers will promptly review these authorizations while others will run them through a vast network of internal lawyers.  

• Circuit diagrams/schematics, which can be challenging to obtain. RF module manufacturers are often reluctant to provide them. You want to know right away if these will be needed.  

You may also need samples of the RF Module or the end-product for in-country testing in each market. Most medical manufacturers will prefer to test the integrated module only to the medical unit itself, wherever this is possible. The medical units are often more expensive than an RF module.  

A deep-dive into in-country testing requires a separate article. However, many countries do not require local testing. Even in some cases where the end unit will be certified, the certification body may just need to see the RF performance of the module. There are also cases where government affiliated labs do not test the module; they just inspect it. You should always verify the local testing procedure and crosscheck with your RF module vendor that the module will not only meet the standards but also comes with the necessary support equipment, software, and clearly translated instructions.  

Compile and provide a list of items you will need from a potential RF module supplier as early as possible. I stress the word potential because, ideally, the response could determine whether you use that supplier at all. If, for example, you approach a supplier with a list of items and they ignore you, equivocate, or state they do not provide these, consider another vendor. Some RF module manufacturers will provide a login to request items. Others may assign a salesperson or project manager. It is important to start a dialogue early in your compliance process.

Restrictions on the Module as a Medical Application

Medical manufacturers should ask if there are limitations on how they can use the wireless module. For example, can the device send medical data off-site? An increasingly interesting question is ‘who regulates this realm’? Does this fall under the wireless/telecommunications authority, ministry of health, or is there joint jurisdiction?  

National Telecommunications agencies still generally dictate all things wireless including SAR (Specific Absorption Rates) requirements. The proximity to the body, frequency, and output power are more consequential to the regulatory decision than the use. That is, it often seems they do not care if it is medical or consumer; they are looking at the numbers. Nonetheless, medical device manufactures need to be acutely aware of SAR requirements and determine if the performance of an integrated module meets country specifications.  

One should also investigate who owns the wireless certification of an integrated module. As mentioned, the module manufacturer ideally has as many country certifications as possible. The device may be compliant, but the question remains: do we need to transfer the certification to our company, the importer, or the end user  

Take the example of on-site paging, at a medical facility, in a European country. The device may be fully compliant with EU RED (formerly R&TTE) directive. The end user at the medical facility would still need to register the device, for some frequencies, with an individual EU country. In other cases, your importer or distributor is bringing a medical device, with wireless technology, through customs. Can he simply show the certificate, which is issued to the wireless module manufacturer? What if the certificate is issued to the local representative for that manufacturer, an entity with no ties to you? There are cases where this is still acceptable. The device is compliant with wireless regulations and that is enough. Importers will often say they want to transfer the certificate to their name anyway to ensure a smoother process. Customs is not always on the same page as the wireless authority and now you are adding in the medical body too. So, despite what the wireless regulations say, it is often wise to listen to your importer.

Medical and wireless regulatory bodies are usually separate. Especially in second- or third-tier markets, there is little to no coordination between them. We can look at the United States for signs this could change. Coordination, if still developing, between the FCC and FDA seems to indicate increasing regulatory concern for wireless transmission in medical applications. We could see this expand to other countries, especially with issues such as privacy in medical data and wearable devices. While these issues pertain more to the general convergence of wireless and medical regulations as they develop, they will impact specific considerations for your module. The key is to understand the regulations for each market, evaluate potential module suppliers and start the compliance process as early as possible in your medical device lifecycle.

We help medical device companies with wireless compliance

Pure Global’s regulatory experts can design a global market access strategy, identify requirements in your target markets, screen suppliers, and compile regulatory documentation for your wireless medical device. Contact us to learn how we can help you obtain global market access for your wireless medical device.

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