The Medical Device Directive (Council Directive 9342EEC of 14 June 1993 concerning medical devices, OJ No L 1691 of 1993-07-12) is intended to harmonize the laws relating to medical devices within the European Union.
The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 200747EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010.
2016 - The Medical Devices Directive is being repealed and replaced by a Medical Device Regulation (MDR).
CE-MARKING: THE PRINCIPLES OF EUROPEAN DIRECTIVES
The European Union (EU) includes the following 27 Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia,Slovenia, Spain, Sweden and United Kingdom. These Member States differ in their constitutional andlegal systems.
Where harmonization of legal requirements or administrative regulations is necessary, the European Commission -the executive body of the European Union- develops regulations, which after acceptanceby the European Council, arecalled Council Directives or simply directives. Each directive describes the consensus that has been achieved and provides a deadline for the transposition of this consensusinto the national laws of each Member State.
In 1985 a European Council Resolution on a new approach to technical harmonization and standards proposed a radical change in regulating the technical aspects of industrial products. The new approach involves the development of legislation specifying only the essential requirements that are general and mandatory. The detailed technical specifications that may be used to demonstrate conformity with the essential requirements are elaborated in voluntary harmonized standards.
Since 1st January 1993, the completion of the internal market has allowed free movement of goods throughout the territory of the European Union. A condition for such freedom of movement is theapplication of technical harmonization directives -also referred to as new approach directives- coveringa wide range of industrial products such as machinery, personal protective equipment, medicaldevices, telecommunication terminal equipment, toys, in-vitro diagnostic medical devices and so on.
The conformity assessment of a product or family of products may require the certification by a Notified Body as regulated in the respective directive. Lists of Notified Bodies, the tasks and responsibilities which have been assigned to them, and their unique four digit identification number is published and updated in the Official Journal of the European Communities.
If certification is a requirement as part of the conformity assessment procedure, the manufacturer has the option to choose any of the Notified Bodies in any of the Member States of the European Union. If a product complies with the requirements of a new approach directive, the manufacturer marks it withthe CE-mark.