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Medical Devices Directives

Medical devices are regulated by legislation which is developed in Europe.  The Medical Devices Directives  are transposed into UK law and enforced by the MHRA.  A CE mark signifies that a device conforms to the Directives.  ABHI seeks to ensure that the Directives continue to provide appropriate and proportionate regulation that balances patient safety and innovation and the association works closely with MHRA on matters concerning implementation.