How are medical devices regulated in the European Union?
The Medical Device Directives are 'New Approach' directives relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. Without the CE mark, the marketing or distribution of the product within the European market is not allowed. The core legal framework consists of three directives:
They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.
Changes to the Directives
Following entry into force of the new Regulations on May 25th, manufacturers have three years to transition to the new Medical Device Regulation and five years to transition to the IVD Regulation. Until manufacturers have transitioned to the new Regulations, the requirements of the relevant Medical Devices Directive will apply.
For more information on the transition between the Directives and Regulations, download our FAQ document for the MDR or IVDR.