VRDP03500 - ‘Designed solely’ equipment: what information should the manufacturer provide?

The manufacturer should be able to provide details of the product including:

  • marketing literature such as brochures and catalogues;
  • any design specifications showing details of the disability or condition which the designer set out to address;
  • any patent applications. Where the manufacturer’s literature indicates that the product is the subject of patents you should consider asking to see the relevant applications - these can give valuable details about the product’s design purpose;
  • details of any clinical trials or tests which have been carried out such as:

(a) On whom were tests carried out?

(b) What medical conditions or disabilities were addressed?

The manufacturer’s marketing literature frequently refers to such tests:

  • endorsements of the product given by disability groups, medical organisations or doctors. Ask for a full copy of what these people had to say;
  • company reports, business forecasts etc detailing sales or projected sales of the product.
  • extent of the market for the product?