Regulatory
The European Directives
Three directives cover medical devices throughout the European Economic Area (EEA):
  • The medical device directive (93/42/EEC) took effect on January 1st 1995. This directive is a general directive covering all medical devices except active implantable medical devices and in-vitro diagnostic medical devices.
  • The in-vitro diagnostic medical device directive (98/79/EC) took effect on June 7th 2000. This directive covers medical devices, equipment, kits and all reagents used to perform a diagnosis on the basis of human specimens.
  • The active implantable medical device directive (90/385/EEC) took effect on January 1st 1993 and covers active implantable medical devices such as pacemakers.

The common format for the three directives is a number of articles covering definitions, scope, free movement, standards and vigilance. Supplementary annexes to the articles cover essential requirements, conformity assessment procedures and classification criteria.

Harmonized standards are developed by European committees to underpin essential requirements and provide technical guidelines for compliance. Whereas compliance with the essential requirements, where applicable, is mandatory, it is voluntary to apply the harmonized standards. A manufacturer who applies the appropriate harmonized standards in the design and production of devices is presumed to be in conformity with the essential requirements of the directive.

Conformity assessment routes are detailed in the annexes of the directives for the various risk classifications. The criteria used to classify the devices rely on the perceived level of risk associated with use of the product; the higher the risk classification, the more stringent the conformity assessment route.

The manufacturer must select an appropriate conformity assessment procedure taking into account both the product risk classification and the strategic route relevant, considering the future plans of the company.

Additionally, the directive requirements mandate manufacturers to implement and maintain a post-market Surveillance and Vigilance System. The manufacturer must notify the regulatory authorities of any incident that might have or have led to death or serious injury.

Except from low-risk classified products that are self-declarable, CE marking requires intervention by an authorised authority. For these products a notified body is selected for assessment of the Technical Dossier and for a complete evaluation to determine product conformity with the directive.

Upon certification the manufacturer can affix the CE mark declaring that the product meets the appropriate, legislative provisions and can be marketed freely anywhere in the EEA.

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