It is not clear if parts/components such as a power cable or battery (used in a medical device that can work on battery power or mains), are defined by the MDD as ACCESSORIES (which require CE marking as a medical accessory) or as SPARE PARTS (which do NOT require CE marking).

On the one hand, the power cable or battery attached to a medical device enable the device to be used in accordance with the use of the medical device as intended by the manufacturer of the medical device - see definition of "accessory" in Article 1, Clause 2(b) of the Medical Directive (MDD 93/42/EEC).

On the other hand, the power cable or battery can be defined as a "spare part" as they are components used in the composition of a medical device or system and are not in themselves medical devices with an intrinsic function intended for the final user.

Any thoughts on this matter?

Thanks.

Asherlee

Provided that the powercable/batteries are OTS then I don't believe there are any requirements to mark them. IF they are specifically designed to fit only this device then they are an integrated part of the design/device and then they would require a CE-mark.