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CC2640R2F: RE-D Declaration of Conformity

user5099613
Prodigy 20 points

Part Number: CC2640R2F
Other Parts Discussed in Thread: CC2640, CC2650MODA

Hello to the community,

I sent the following questions via general TI e-mail correspondence and received the request to post the questions in the e2e forum. I am not sure if this topic is in the right section of the forum, please suggest me a better section if this one is not the best one.

Here are the questions:

"We will implement the CC2640R2F_RHB in a medical device on a medium scale (At least 5000 devices until the end of 2019) and sell it on the EU market.

To have full conformity, we have to guarantee that the Bluetooth part of the chip meets the requirements of the European Radio Equipment Directive (RE-D).

Do you have declarations of conformity that the given chip is compatible with RE-D and furthermore with all the necessary applicable norms, especially the ETSI EN 300 328 norm for Bluetooth modules?

If not, is TI planning to receive these DoCs and if yes, when is it estimated to provide the certificates."

Thank you very much for your help and best regards,

Tibor

  • 0
    TI__Guru** 106705 points
    HI Tibor,

    While we do not usually publish our DoCs for BLE kits, the CC26xx devices are designed to pass all common regulatory requirements. Additionally all evaluation boards are CE marked and have thus passed RED certification, more specifically ETSI EN 300 328 for the the CC2640R2 LaunchPad.

    You can read more about certification on our BLE wiki: www.ti.com/ble-wiki

    Cheers,
    Fredrik
  • 0 in reply to Fredrik K
    Prodigy 20 points
    Hello Fredrik,

    thank you for your answer and the provided information. In this case, we will stick to the layout rules provided by TI for the CC2640 and this measure should be enough to convince the authorities that the device is compatible with EU regulations.

    Best regards,

    Tibor
  • 0 in reply to user5099613
    TI__Guru** 106705 points
    Hi Tibor,

    The RF performance of a product is not dictated by the RF chip alone, but also external factors, such as layout, components, housing, etc. Doing a regulatory conformance qualification is thus required for your application even though our reference designs are certified. The only exception to this is if you use a pre-certified RF module such as the CC2650MODA.

    Regards,
    Fredrik