§ Lord Ashley of Stokeasked Her Majesty's Government:
Why they consider it necessary to ascertain that digital hearing aids are safe and effective. [HL831]
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Hayman)All hearing aids are defined as medical devices under the European Medical Devices Directive. This directive has been enacted in United Kingdom legislation as the Medical Devices Regulations 1994. The regulations require medical devices to meet appropriate standards of safety, quality and efficacy. The manufacturer has to demonstrate compliance with these regulations. Depending upon the potential risk posed by a device, compliance may involve a self-declaration of conformity, independent type testing or quality auditing of the manufacturing facility.