Using the law to develop and improve equipment and adaptation provision
Consumer Protection Act 1987 [Part 1] and Medical Devices Regulations 1994
7.1. Consumer Protection Act 1987, Part 1. This Act imposes strict liability, albeit with some defences, on manufacturers for harm caused to consumers by defective products. The liability might instead be incurred by a supplier [e.g. a local authority or the NHS], if it cannot identify either the manufacturer or at least the supplier from which it obtained the equipment. Local authorities or the NHS may themselves be manufacturers for the purpose of the Act [for instance in an occupational therapy workshop], if they either manufacture their own equipment or adapt existing equipment so significantly as in effect to create a new product [see also Circular SHHD/DGM20, issued with the coming into force of the Act].
7.2. Medical Devices Regulations 1994. These regulations impose a number of duties on manufacturers of equipment. For `low risk', Class 1 devices with which this document is mainly concerned - the manufacturer places a CE mark on a product, which in effect is a statement that the product meets certain `essential requirements' in terms of safety and performance. Customised medical devices have likewise to meet the essential requirements but must not have a CE mark placed on them.
If NHS and local authority equipment and adaptation services modify equipment, they might invalidate the CE marking, thus giving the manufacturer a defence if something subsequently goes wrong with the product. If a product is modified beyond a certain point, the equipment is likely to become a new product - and thus the modifier becomes in effect the manufacturer for the purpose of the Regulations [although there is some doubt about the circumstances in which the regulations apply to the NHS as manufacturer: advice should be sought on this point from the Medical Devices Agency, the United Kingdom-wide body responsible for the Medical Devices Regulations 1994].