The Medical Devices Directive is important to you if you manufacture or distribute medical devices within the European Economic Area.
Your route to conformity
The 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. However guidance on classification of your devices and which assessment route is most appropriate to meet your business needs is available directly from the LRQA Medical Devices team.
Devices covered by the MDD are grouped into four classes, according to the level of risk they present. The classification determines the choice of conformity assessment available to you.
Your next step
Under the MDD 93/42/EEC, LRQA is a notified body for medical devices using the quality system conformity routes - Annexes II, V and VI. You will need to complete a simple form letting us know about your company and your products. We will use this information to verify the requirements relating to your products and to work with you to determine the best options for conformity assessment including any other service we can help you with.
For a copy of the form or for further information, please call 0800 783 2179 or complete the enquiry form on this website for further information.
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