Wireless RF Regulations and Standards for Medical Devices sold in the EU

whoosh929

Registered
Hello all,
Medical devices in the US that utilize RF technology (i.e. wireless communication) need to follow CFR FCC part 15. What is the equivalent regulation for marketing outside the United States (specifically, the EU)?

For reference, my medical device is both hardware and software that connects to a WiFi access points in a hospital and communicates data to specific end points on the network.

Thanks in advance for your help.
 

QAengineer13

Quite Involved in Discussions
Hello all,
Medical devices in the US that utilize RF technology (i.e. wireless communication) need to follow CFR FCC part 15. What is the equivalent regulation for marketing outside the United States (specifically, the EU)?

For reference, my medical device is both hardware and software that connects to a WiFi access points in a hospital and communicates data to specific end points on the network.

Thanks in advance for your help.
Hi Whoosh929,

For EU, you need to comply to the new Radio Equipment Directive (RED) 2014/53/EU.
REF: (broken link removed)

These RF regulations are independent to the Medical Device / IVD regulations and different countries have different regulatory agency for the Telecommunication for example) Brazil its governed through ANATEL, Mexico its COFETEL, Japan VCCI and these regulations also mandates certain labeling requirements as well. Hope this helps
 

shimonv

Trusted Information Resource
And you refer to the following link for a specific list of standards that forms the basis for compliance with EU regulation.

(broken link removed)


Best,
Shimon
 
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