Regulations and Directives—Past, Present, Future

Abstract

Regulations are binding acts which are obligatory in the European Union. All members of the European Union must apply Regulations. On the other hand, there are Directives, legislative acts which represent the base setting the goal which has to be achieved by EU countries for a specific area. Each EU country has individual national laws in order to achieve that goal. Directives which regulate harmonized products in the EU are known as New Approach Directives. One of the Directives which belong to the group of the New Approach is Directive 93/42/EEC on medical devices. The integral part of a Directive is Harmonised Standard which serves Manufacturers, other economic operators, or conformity assessment bodies to demonstrate that products, services, or processes comply with relevant EU legislation. Conformity assessment is a process that is performed by the manufacturer in order to demonstrate if all specific requirements related to the product have been met. Conformity assessment is provided by a competent body (notified bodies) and differs for different classification of medical devices. There are different approaches in conformity assessment of medical devices in the EU and USA which are described in this chapter. Many European countries have recognised the importance of metrology and its influence in providing services which will ensure accurate and precise measurements of medical devices that have a measurement function.