Is Energy Labelling Directive appliable to the Medical Devices?

S

ShareKing

Hello, all,

I'm working on the DoC of medical product that uses Computer mother boards as the central piece and it integrates LED lights, power supply and liquid-Crystal display as well. By reviewing the directives in the blue guide, I noticed that the MDD and RoHS are appliable. However the Energy Labelling Directive 2010/30/EU seems to be controversary.

It is no doubt that the product is an energy-related Product and it falls in the scope of the directive. However, there is no Guidelines for the ecodesign of medical devices. Therefore the question is:

Is the Energy Labelling Directive appliable for the product?
If yes, should I in the DoC explicitly exclaim the conformity?
If yes, which material should be included in the technical Documentation to give evidence of conformity?

Thank you!

Qing
 

somashekar

Leader
Admin
Hello, all,

I'm working on the DoC of medical product that uses Computer mother boards as the central piece and it integrates LED lights, power supply and liquid-Crystal display as well. By reviewing the directives in the blue guide, I noticed that the MDD and RoHS are appliable. However the Energy Labelling Directive 2010/30/EU seems to be controversary.

It is no doubt that the product is an energy-related Product and it falls in the scope of the directive. However, there is no Guidelines for the ecodesign of medical devices. Therefore the question is:

Is the Energy Labelling Directive appliable for the product?
If yes, should I in the DoC explicitly exclaim the conformity?
If yes, which material should be included in the technical Documentation to give evidence of conformity?

Thank you!

Qing
Good though.
Medical device word is not found in the directive. The definitions in the 2010/30/EU says Energy related product as " goods having an impact on energy consumption during use "

I found this in the FAQ on the Energy Labelling Directive and its Implementing Regulations
(Not legally binding. Last updated October 2014. This document will be regularly updated.)

(1) Question on lamps and LED modules with luminous flux of less than 30 lumen
It is stipulated in Article 1.2a) that lamps and LED modules with a luminous flux of less than 30 lumen shall be excluded from the scope of the regulation. Does this mean that it does not matter how many lamps the luminaire has as long as all of them separately have a luminous flux of less than 30 lumen? If the lamps are attached to a luminaire and are not exchangeable are you then supposed to add the lamps luminous flux together to see if the requirements (less than a luminous flux of 30 lumen) are met?
(1) Answer on lamps and LED modules with luminous flux of less than 30 lumen
LED modules not intended to be removed by the end-user from the luminaire do not need to be labelled at all (Article 2(d)). It is the luminaire itself which will get the luminaire label, regardless of its light output or that of its LED modules. The label for LED luminaires only shows that the incorporated lamps are LEDs and that they belong to classes A to A++, without more precise allocation, and without any testing to be done other than checking that the included light sources are indeed LEDs. When LED modules are sold as spare parts, they have to be labelled and they are indeed excluded under 30 lumens. This is coherent with the exclusion of other replacement lamps under 30 lumens, which could equally be present in a luminaire in high quantities, adding up to substantial light output.

May be this will set some direction.

I see this directive applicable to Electrical and Electronic appliances, Lighting, and several type of heaters and storage equipment.
 
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