EU ECO Design Regulation Implementation impacting External Power Supplies

Dear members, please see below notification regarding EU ECO Design Regulation Implementation impacting External Power Supplies

Note that although External Powers Supplies designed, tested and exclusively marketed for use with medical devices are exempt, External Power Supplies associated with off the shelf IT equipment are not, this includes Off the shelf equipment supplied with IVDs, especially if imported from outside the EU.

This implementation legislation is also likely to be adopted for equipment placed on the Northern Ireland market.

Note that EU MDR Article 2(1) includes IVD medical devices.

EU MDR Article 2(1)

(1)

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

—	diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

—	diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

—	investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

—	providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

—	devices for the control or support of conception;

—	products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

We are writing to inform you of the publication in the EU Official Journal of one of the ecodesign requirements for energy-related products, laying down ecodesign requirements for external power supplies, wireless chargers, wireless charging pads, battery chargers for portable batteries of general use and USB Type-C cables, pursuant to Directive 2009/125/EC of the European Parliament and the Council and repealing Commission Regulation (EU) 2019/1782.

The Regulation sets out requirements regarding energy efficiency, power output performance, interoperability, surge resistibility for interoperable EPS, information, and technical documentation.

Please note, there is a reference to medical devices in Article 1(1)(e), which states that this Regulation shall not apply to “EPS designed, tested and marketed to be used exclusively with medical devices, as defined in Article 2(1) of Regulation (EU) 2017/745”.

We will keep members informed about any future developments regarding ecodesign.

In case of further questions or comments, please do not hesitate to reach out.

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EU ECO Design Regulation Implementation impacting External Power Supplies

EU ECO Design Regulation Implementation impacting External Power Supplies

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