Radio Directive question about Wireless Device to Device Communication

M

misterblonde

#1
I have been tasked with getting a new product of ours to be CE compliant, and am I am having some issues with the radio and telecommunications directive, if some one could help me understand it that would be greatly appreciated.

My question is basically, would our product need to satisfy this directive?

Our product uses radio waves to communicate between each other wirelessly and that is all. Am I reading the directive right that we would not need to conform to this directive? I have been searching around on this site and others to some rather contradictory information. Does anyone have any experience with this?

Thank you in advance for your help.
 
Elsmar Forum Sponsor
#2
Hi,
the R&TTE directive does apply to medical devices. Please refer to Article 1 of 1999/5/EC:
"Where apparatus as defined in Article 2(a) incorporates,
as an integral part, or as an accessory:
(a) a medical device within the meaning of Article 1 of
Council Directive 93/42/EEC of 14 June 1993
concerning medical devices (1), or
(b) an active implantable medical device within the
meaning of Article 1 of Council Directive 90/
385/EEC of 20 June 1990 on the approximation of
the laws of the Member States relating to active
implantable medical devices (2),
the apparatus shall be governed by this Directive, without
prejudice to the application of Directives 93/42/EEC
and
90/385/EEC to medical devices and active implantable
medical devices, respectively."

You might want to check if you are using an off the shelf radio module. The manufacturer of the wireless module may have issued a 1999/5/EC declaration of conformity already. This would safe you some work.

Best regards,
 
M

misterblonde

#3
Thank you for your response, however, our product is not a medical device, so this part of the directive does not apply.

The radio we are using in our product is FCC and IC compliant and states that to get CE compliant it is the OEMs responsibility. So this makes me think it is plausible, I would just like to make sure.
The radio uses a host interface of IEEE 802.11b,g,a, that was designed for WLAN applications. I am having a difficult time finding anywhere in 1999/5/EC that says explicitly what types of radios must be compliant and which do not.
 

CharlieUK

Quite Involved in Discussions
#4
WLAN applications are "short range devices" - information on various classes of SRD is available by searching for: CEPT SRD sub classes (newbie so can't post links yet)

List of Harmonised Standards is available at by searching for: Europa R&TTE Directive Harmonised Standard list

Bluetooth/WiFi devices operating in the 2.4 GHz band that comply with FCC requirements are likely to comply with EU requirements.
For devices operating in the 5.x GHz band it is not so simple.

The R&TTE Directive requires that the manufacturer "Fully Applies" RF spectum standards otherwise a Notified Body Opinion is required.
 
D

dionysisf

#5
Hello, I found this post and I am adding a question further to the above replies:

My company produces Medical Devices, Class IIb, CE marked under 93/42/EC, and we are going to incorporate a WiFi module and GPRS module for communication. Do we have to conform with R&TTE directive 1999/5/EC?

Thanks in advance for your help!
 

CharlieUK

Quite Involved in Discussions
#6
Yes, a medical device containing one or more radio devices must also conform to the R&TTE Directive.

Note: Radio Equipment Directive, 2014/53/EU will need to be applied from 13 June 2017, and whilst it can be used now, it is easier to use R&TTE at the present time
 
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