Abstract

REGULATORY REQUIREMENTS FOR CE CERTIFICATION OF MEDICAL DEVICES IN EUROPEAN UNION

Gottipati Meghana*, M. V. Nagabhushanam and M. Beena Devi

ABSTRACT

The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member‘s states of the EuropeanEconomic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.

Keywords: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.