Wipes and CE marking

A number of our customers are facing confusion regarding the CE marking of the sterile wipes that they are using in aseptic preparation.

If a product is classified as a medical device as specified in the medical devices directive 93/42/EEC, then it must be CE marked.

SteriClean wipes are not classified as a medical device and therefore should not and cannot be CE marked.

With reference to the guide ‘Quality assurance of Aseptic Preparation Services’ fourth edition, P57 chapter 13, 13.2.1, sterile wipes are classified as a component and should be supplied with a documented from of approval, which in this case will be a sterility certificate.

I hope this clarifies the issue and for more information and samples of our SteriClean range of wipes please call 0800 0328 428

http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con057319.pdf