Originally Published MX May/June 2004

INFORMATION TECHNOLOGIES

Under the European Union's new environmental directives, IT compliance is about to take on a whole new dimension.

Chris Wong

Medical device manufacturers are no strangers to the necessity of meeting compliance requirements set by FDA. Managing the constraints and accountability related to such regulations is part and parcel of the medical technology business. However, regulation is set to take on a whole new dimension with emerging environmental directives from the European Union (EU), which will require medical device companies to change the way they develop and bring their products to market.

The EU's new environmental directives are not up for debate, and their reach is widespread. They will affect many of the devices found in hospitals and clinics around the world—from simple electronic thermometers to such complex systems as radiotherapy equipment, dialysis machines, and ventilators. The only notable exemption is for medical devices that are considered "implanted or infected," such as pacemakers.