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.
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, VI
LRQA is able to perform product conformity assessment and certification activities against the directive such as:
- Auditing - a company's quality system
- Design dossier - conducting design dossier examinations for Class III devices
- Verification - verifying that your technical documentation meets the requirements of the directive and is implemented within the system
- Verification - carrying out verification of manufactured batches of defined high risk IVDs
- Continued surveillance - conducting continued surveillance of the quality system.