Certification of Medical Devices

Under UK and EU law, any device sold for the prevention or relief of disease is a “Medical Device”. There are several classes, according to the severity of the clinical state and the sophistication of the intervention.

Specialised bedding for asthma or allergies is a “Class 1 Medical Device”. As such, the manufacturer should be registered with the particular country’s regulatory authority – in the UK, the Medical Devices Agency. The Manufacturer should provide evidence that the device is fit for the intended purpose and affix a “CE” mark of conformity to each product.

Advanced Allergy Technologies export a high proportion of it’s production to other EU countries, where neither the end users, nor the insurance companies who re-imburse the cost would accept the product without this re-assurance.

We very much regret that many potential consumers are unaware of these regulations and that they seem unenforced in the UK. We are aware of only one other allergen bedding system on sale in the UK carrying a “CE” Mark. 13 of 14 competing products we have tested were totally inadequate allergen/particle barriers. You have been warned!

In addition to the official Europe-wide CE system, some countries have independent testing agencies. The textiles used in our bedding products have been tested by the British Textile Technology Group and finished Alprotec bedcovers by the Consumer's Association in the UK.