The Medical Device Directive is a piece of legislation that was passed in the European Union in 1993 to establish standards for medical devices sold in member nations. Creating harmonized legislation to use across the European Union for monitoring the production and sale of medical devices, it streamlined the process of approving medical devices for use and sale while providing a regulatory framework for safety. Companies interested in selling medical devices in EU nations must conform with the Medical Device Directive.
Also known as 93/42/EC concerning medical devices, this directive classifies medical devices by risk, ranging from relatively low risk accessories like wheelchairs to high risk products like catheters. Within each risk category, individual subcategories have been created. People who want to sell medical devices must provide technical documentation on the products, have a representative in the European Union, and issue a declaration of conformity with shipments of their products. In addition, a CE marking must identify the devices, indicating they comply with the Medical Device Directive.
Devices are certified for both safety and reliability, according to standards set in the Medical Device Directive. This directive does not cover active implantable devices like infusion pumps. These devices are covered in the Active Implantable Medical Device Directive, a separate piece of legislation. The European market for medical devices is large, as many EU members provide advanced medical care to their residents, and companies may hire consultants to work on making their devices conform with the Medical Device Directive so they can market and sell their products in the EU.
The framework of this directive is complex and can be confusing. Consulting firms familiar with the directive can provide people with guidance while they work on getting products into the European Union and develop new products for sale in the EU. Medical device manufacturers in the European Union may retain staff members responsible for implementing the Medical Device Directive in the company, auditing the process of developing products, and working with government representatives to obtain certification.
Similar laws can be seen in place in many other regions of the world for the protection of patients. Devices from tongue depressors to pacemakers are regulated by law to ensure they are effective and safe to use. Frameworks for recall of damaged, defective, and potentially dangerous devices are also in place, allowing government regulators to act quickly if they identify a problem with a medical device or manufacturer.