Understanding CE marking and why Endurocide® products don’t have it

We are frequently asked whether Endurocide® products have a CE mark. In order to clarify why we don’t, we thought it would be good to give you some background information on the CE marking process in the UK.

Registered Medical Devices - such as endoscopes - carry the CE mark. Biocides can be awarded the CE mark if registered for cleaning medical devices.

The CE mark and its registration number, indicating the type of Medical Device, has to be clearly shown on the packaging label. However, our disinfection products are designed for hard surface cleaning and, in the UK, this would require two separate products to be created as surface cleaning is not a Medical Device.

In the UK, the law on CE marking is clear:

"Only products that are specifically intended for the disinfection of medical devices are considered to be medical devices and may be CE marked under the medical device regulations.  Products that are intended to be used as multi-purpose hard surface disinfectants/cleansers and/or general environmental disinfectants are not considered to come within the remit of the medical device regulations.  There is no provision under the medical device regulations for disinfectants labelled primarily for use with medical devices with subsidiary claims for multi-purpose use, therefore such products should be marked separately under the different sets of legislation."

In some parts of the EU it is not necessary to market separately, the assumption being that the user recognises that the CE rating applies only to the medical device.

For more information, please contact us.

Disclaimer:

Whilst every effort has been made to ensure the information presented above was correct at time of publication, Bio Technics Ltd., does not assume any liability to any party for any errors or omissions. The above information is supplied for guidance only and is without guarantee. Any opinions expressed in this document are not necessarily those of Bio Technics Ltd. and are not for onward publication without consent.