European Medical Devices Regulations


18 September 2003

Medical Devices standard ISO 13485:2003 will be the focus of the inaugural meeting of the Institute of Quality Assurance's (IQA) Medical Devices Quality Group in association with the American Society of Quality (ASQ) today, 18 September 2003. The Royal Pharmaceutical Society of Great Britain will be hosting this event, which includes speakers from both the USA and the UK.

The standard is a model for regulatory compliance, focused on achieving, maintaining and improving compliance with regulatory requirements and producing safe medical devices.

It is anticipated that ISO 13485:2003 will be adopted as the basis for quality systems requirements for selling medical devices in many international markets. It provides a model for addressing the quality system requirements of the European Medical Devices Directive. In addition, it will be adopted by Health Canada for their regulations and is compatible with the US FDA's quality system requirements.

Speaking at the conference, Paul Brooks, an assistant vice president of BSI based in the USA, said:

"For the many medical devices manufacturers who already meet existing standards, the transition to ISO 13485:2003 will not be too complicated.

"The role of top management, however, is crucial. They will be expected to lead moves towards adoption of the new standard by driving all the details of change into the organisation.

"Quality policy must form the framework for objectives, and all objectives must be measurable."