The CE mark

There is a legal requirement that all products sold in Europe should carry the CE mark. It is the highest quality standard in Europe for condoms, which are now classed as medical devices, and is recognised as mandatory by the NHS, the Department of Health (DOH) and the Medical and Healthcare products Regulatory Agency (MHRA).

The CE mark was introduced to harmonise the safety and fitness for use of condoms across Europe with the aim of reducing confusion and barriers to trade.. This enables customers to purchase condoms in any country in Europe, knowing that their condoms meet standard ISO 13485:2003 which is the European recognised level of quality for condoms. Many European countries have in the past had their own standards which have differed in detail and test methods. This is why the European Medical Devices Directive (93/42/EEC) came into force in 1998 and required manufacturers to fully implement its requirements.

Originally enforced by the Medical Devices Agency (MDA) in the UK, there is now only one legal requirement for medical devices and condoms to conform to and that is the European Directive.

The British Standards Institute (BSI) Kite Mark was introduced prior to the establishment of any other controls being in place in the UK. BSI have adopted the European Standard and, in fact, the same quality standard applies, but the Kite Mark can no longer stand alone. It is, in fact, illegal to trade with the Kite Mark alone. All products which carry the Kite Mark must carry the CE mark as well. Therefore it is the CE mark that users should look for first, to ensure the quality of the product.

Condomania are proud to carry the CE mark on all their products and should you require any further information please contact us direct - info@sexualhealthgroup.com