Medical Case Study – Power Assisted Baths

The Medical Case Study

Gainsborough Baths have been designing and manufacturing high quality power assisted baths for the care sector for over 20 years. They were visited by a local Trading Standards Officer regarding a competitor product incident, only to find out that Gainsborough products were different in design. This medical case study is how the CE Marking Association helped the company to bring their products in line with the CE Marking requirements of the current legislation. Additionally, Gainsborough had plans for 3 new products to be launched over the coming years, and so was an ideal opportunity to get their product compliance in order.

The Medical Devices Directive (93/42/EEC, as amended) sets out product requirements for devices which are intended to diagnose, monitor, treat or alleviate, or prevent, disease; or compensate for an injury or handicap; investigate, replace or modify the anatomy; or control conception. Power assisted baths had the potential to fall within the scope of the Medical Devices Directive, but could have also fallen within scope of other CE Marking legislation, and in this case it all depends upon the manufacturer’s intended use of their product.

With the support of both MAS-WM (Manufacturing Advisory Service – West Midlands) and Black Country Business Link, the CE Marking Association was able to help Gainsborough Baths to understand their requirements and make a decision as to whether to CE mark their products as Medical Devices or not. Following the decisions made by Gainsborough, we carried out all of the necessary conformity assessments and compiled the necessary technical documentation to enable Gainsborough to demonstrate compliance when the Trading Standards officer returned a visit.

The Result

The success of Gainsborough’s products and the ability to demonstrate compliance has enabled the business to expand from 200 to 300 baths per year. The CE Marking Association and Wemtech have completed approximately 200 projects for MAS nationally and we welcome your calls to discuss any queries on product compliance. Please contact us on 01527 595066.

For more help and advice on product conformity for Medical and similar devices, please call us on 01564 792349