What is the Medical Devices Directive?
The Medical Devices Directive is important to you if you manufacture or distribute medical devices within the European Economic Area. What does the directive cover? 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 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. Our services 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 such as: -audit a company’s quality system -cond
