Medical Devices Directive
93/42/EEC
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
- 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
- conduct continued surveillance of the quality system.
Next steps
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