📣 ODEP and Beyond Compliance respond to the report of the Independent Medicines and Medical Devices Safety Review - 'FIRST DO NO HARM'
Please click here
to read our response in full.
*** To View the list of Beyond Compliance products, please visit the Products section of the ODEP Website and filter the products by the Pre-Entry A* rating ***
Beyond Compliance is a service to support the safe and stepwise introduction of new or modified implantable medical devices.
An independent panel of experts, known as the Beyond Compliance Advisory Group, work with the implant manufacturer to assess the relative risk of any new product, and the rate at which it should be introduced to the market. The service collects data about patients who receive these implants and about their recovery following surgery. This data is made available to clinicians using the implant, to the manufacturer, and to independent assessors from the Beyond Compliance Advisory Group, to provide real-time monitoring of the implant’s performance. The clinicians who agree to joining the advisory group are drawn from the most experienced and respected members of their field.
Beyond Compliance is an optional service available to implant manufacturers. The service commenced in the field of joint replacement implants. Following the success of the introduction of Beyond Compliance to Orthopaedic there are now plans for it to be extended for use with other implantable medical devices.