Regulatory Open Forum

Hi all

Here in Europe we are experiencing some excitement about the amendment (2022/2380/EU) to the directive on radio equipment 2014/53/EU. From my perspective the intention is on standardizing on the USB-C cable for charging electronic CONSUMER equipment. However, the wording isn't clear enough for me, and this is what I would like to clarify.

If a medical device contains a certified WLAN module to communicate with another device and is NOT itself a handheld mobile phone, tablet, digital camera, etc. (see Annex Ia of 2022/2380/EU), then it doesn't need to be charged using a USB cable. Is this correct?

In my case, we have a medical device talking to a auxilary display by WLAN. Our device uses a medical grade charger with an internal isolation from the supply mains (IEC 60601-1). Requiring an of-the-shelf USB charger to charge our device would necessitate signification architectural redesign with little gains for the user.

Thank you for your input.

Hi Richard

That's how I read it, too. Consumer products per Annex Ia. Was there a particular section that made you think the scope might be broader?

Hi all

Here in Europe we are experiencing some excitement about the amendment (2022/2380/EU) to the directive on radio equipment 2014/53/EU. From my perspective the intention is on standardizing on the USB-C cable for charging electronic CONSUMER equipment. However, the wording isn't clear enough for me, and this is what I would like to clarify.

If a medical device contains a certified WLAN module to communicate with another device and is NOT itself a handheld mobile phone, tablet, digital camera, etc. (see Annex Ia of 2022/2380/EU), then it doesn't need to be charged using a USB cable. Is this correct?

In my case, we have a medical device talking to a auxilary display by WLAN. Our device uses a medical grade charger with an internal isolation from the supply mains (IEC 60601-1). Requiring an of-the-shelf USB charger to charge our device would necessitate signification architectural redesign with little gains for the user.

Thank you for your input.

Hi Anne

My uncertainty stems from the fact that 2022/2380/EU amends the Essential Requirements (Art. 3) of 2014/53/EU. It now requires that the radio equipment within certain categories or classes shall be so constructed that it complies with the following essential requirements: "radio equipment interworks with accessories other than the charging devices for the categories or classes of radio equipment, specified in Part I of Annex Ia, which are specifically referred to in paragraph 4 of this Article;';"

I feel this statement can be understood from the perspective of a medical device or from that of "mobile phones and a number of other small portable devices". But, after reading some pre-publications of the EU parlament, it seems they mean that latter ones. Thus, it seems to only apply to "mobile phones and a number of other small portable devices".

Hi Richard

That's how I read it, too. Consumer products per Annex Ia. Was there a particular section that made you think the scope might be broader?

Hi all

Here in Europe we are experiencing some excitement about the amendment (2022/2380/EU) to the directive on radio equipment 2014/53/EU. From my perspective the intention is on standardizing on the USB-C cable for charging electronic CONSUMER equipment. However, the wording isn't clear enough for me, and this is what I would like to clarify.

If a medical device contains a certified WLAN module to communicate with another device and is NOT itself a handheld mobile phone, tablet, digital camera, etc. (see Annex Ia of 2022/2380/EU), then it doesn't need to be charged using a USB cable. Is this correct?

In my case, we have a medical device talking to a auxilary display by WLAN. Our device uses a medical grade charger with an internal isolation from the supply mains (IEC 60601-1). Requiring an of-the-shelf USB charger to charge our device would necessitate signification architectural redesign with little gains for the user.

Thank you for your input.