Feb 10, 2016

Medical device manufacturers are increasingly adding wireless technology to their products, but how does this trend impact regulatory compliance?

From cellular links to patient data transmission to basic Wi-Fi to remove cords in n operating rooms, these applications continue to evolve. Bluetooth is especially popular with medical technology manufacturers. From a compliance and regulatory standpoint, Bluetooth has several benefits. Most importantly, it is widely accepted across the world. Although Bluetooth is a common application (or perhaps because it is so common) many manufacturers fail to consider a few basic regulatory items.

  1. You need to approve Bluetooth technology in most countries. If you are looking to sell your Bluetooth-enabled medical device outside the US and Europe, chances are you will need to approve it with the wireless regulatory agency in each country. The certification process can range from a simple notification to having to test the device at a local laboratory. It is important to know the regulations of each country as soon as possible.
  2. The manufacturer of the Bluetooth module may already have some country certifications. Check this to avoid extra work. In many cases, you need to approve your end medical unit (as opposed to just the Bluetooth module) but having the Bluetooth certification will help.
  3. How old is your Bluetooth module? Bluetooth has been around a while. So, the module may work great but the manufacturer may have outdated test reports. Many countries won’t accept test reports over five years old.
  4. Is the Bluetooth manufacturer “there?” If you are looking to sell your product in a remote country, it is unlikely the Bluetooth manufacturer will have certification for that market. But you will still need the manufacturer to provide product materials (such as test reports, block diagrams etc.) so you can apply for approval in that country. It is important to check if they are willing and able to help with this.
  5. Bluetooth Only? If you are considering adding more than one wireless component, it is best—if at all possible—to add them both at once. For example, certifying a product with Bluetooth and a cellular modem is easier than certifying a product with Bluetooth, then coming back in six months and adding the cellular component.

International wireless compliance for a Bluetooth-enabled medical device does not need to be difficult. Follow these guidelines, start the compliance process early, and you’ll be ready to launch your product around the world. 

For more information on regulatory considerations for wireless medical technologies, download our whitepaper on the topic.


  • Emergo Marketing (not verified)