Medicated and alcohol based wipes and swabs

Medicated swabs/ wipes intended for a medical purpose on humans (for example pre-injection swabs, wound cleansers or for use in a first aid kit) have historically been regulated as medicinal products. Some contain either antiseptics such as chlorhexidine, cetrimide or iodine, but others are alcohol based with no other active ingredient.

MHRA has undertaken a comprehensive review of these types of products in the light of a number of queries regarding their regulatory status and differing views on the appropriate regulatory route within the EU. As a result of this review, MHRA has determined that wipes / swabs containing antiseptics / antimicrobials such as chlorhexidine, iodine, cetrimide and similar will remain as medicinal products and therefore will continue to require a Marketing Authorisation.

Alcohol wipes (i.e. those containing alcohols and water but no other ingredients), however, have a non-specific action. MHRA has determined that there is no reason why such alcohol wipes might not be regulated as medical devices.

As a result of this determination, MHRA will accept the placing on the market of alcohol based swabs / wipes as medical devices. Such products will therefore require to be CE marked under the Medical Device Regulations. Products placed on the market specifically for use ONLY on unbroken skin would be likely to be considered as Class I devices, whilst those for use on injured / broken skin would be likely to be regarded as Class IIa devices.

It should be noted, however, that the position that MHRA has adopted with respect to the regulation of alcohol wipes may be revised in the event of a European Consensus being reached on the regulation of these products.