NEW PROPOSAL FOR EUROPEAN UNION REGULATIONS ON MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES

Medical devices: new regulations, new responsibilities.

How are medical devices regulated in the European Union?

The Medical Technology Evaluation Programme (MTEP) within the National Institute for Health and Clinical Excellence (NICE) was set up in 2009; this is a programme focusing specifically on the selection and evaluation of new or innovative medical technologies (including devices and diagnostics). One of the requirements to enable a product to be evaluated by the MTEP is that the device is CE mark...

Regulation of medical devices outside the European Union

The regulation of medical devices across the world is very varied, ranging from comprehensive to none. Over the past two decades, the number, range, and complexity of medical devices has increased. Regulation of these devices has also evolved due to an increasing awareness of the need for a more consistent approach to regulatory documentation. This will aid both manufacturers selling a product ...

Coding System Design for Medicines and Medical Devices in Iran

Background and Aim: The importance of managing medicines and medical devices as vital resources in healthcare industry cannot be ignored. Therefore, the application of coding systems could be of great help in the control of the required processes. This study aims to develop a coding system for medicines and medical devices in Iran. Materials & Methods: This descriptive study was planned to be ...

Regulation of medical devices in the United States and European Union.

Millions of patients worldwide depend on an everwidening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device ...