93/42/EEC Medical Device Directive: Medical
The 93/42/EEC Directive helps manage the quality manufacture of medical devices...
Certification to 93/42/EEC is not only advantageous - it is stipulated if you manufacture or distribute medical devices within the European Economic Area. In fact, products must conform to the Medical Device Directive (93/42/EEC) before they can be placed on the market within the European Economic Area and manufacturers have to demonstrate their product's conformity to the Directive by affixing the CE Mark.
What is the CE Mark?
The CE marking signifies that a manufacturer has declared that a product conforms to the requirements of the Directive (and any other Directives that may apply to it), and is safe for use within the European Economic Area. The CE mark alone is not a quality mark.
What is 93/42/EEC?
The 93/42/EEC Directive covers all products which claim to have a medical purpose and which are used in and on the human body, from heart valves to scalpels, excluding in vitro diagnostics, which are covered in a separate directive.
The exact definition of which products are covered can be found in the directive itself, along with a set of rules which help the manufacturer determine what classification the product is. Information on the directive and a copy of the directive text can be found on the European Commission website.
How can we gain certification to 93/42/EEC?
Under the medical devices directive, LRQA is designated as a notified body for medical devices using the quality system conformity routes laid out in Annexes II, V and VI.
LRQA is able to perform conformity assessment activities against the directive, including:
audit a company's quality system
conduct design dossier examinations for Class III devices
verify that your technical documentation meets the requirements of the directive and is implemented within the quality system, and
conduct continued surveillance of the quality system.
Next steps...
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