Critical review

Before a medical device can be sold in the EU it must meet the requirements of the European Medical Devices Directive. These include the maintenance of a Technical File containing evidence of safety and efficacy, and within that Technical File a Critical Review of pertinent literature and research.

A Critical Review is not intended to be a piece of scientific research in its own right or necessarily to reach the standards required for publication in a peer-reviewed journal. Its function is to act as an overview of pre-existing research and to provide copious references forming a clear 'audit trail' of supporting scientific evidence.

The Critical Review underlying electronic microbicidal technology can be found here, together with a list of micro-organisms against which the techniques has been proved effective and a list of conditions against which efficacy is claimed. Please note that the national body charged with enforcing the Medical Devices Directive (MDD) within the country of manufacture (in the UK the Medicines and Healthcare Products Regulatory Agency) must be satisfied that there is sufficient proof of efficacy for each 'claimed' condition. It is illegal to offer for sale any device for which unsubstantiated claims are made or which in any other way fails to meet the criteria laid down by the MDD.