Accessory (CE required) or Spare Part (no CE)

[Asherlee]

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

[Gert Sorensen]

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.