The CE mark is “Compliance”. What if we invited manufacturers to go “Beyond Compliance” in a completely voluntary way? That turned out to be the basis of the introduction of the “Beyond Compliance” system. Beyond Compliance had the backing of MHRA, ABHI, the BOA from the outset. The then Minister of Health, the Rt. Hon. Jeremy Hunt supported it (paywall).
Peter Kay FRCS was appointed to head the steering committee.
ODEP was approached and asked if they would provide the manpower to staff the advisory group which Keith Tucker was asked to chair.
The duties of the advisory group include
1. Perform an in depth assessment of new Hip and Knee replacements that were brought to it by a manufacturer
2. Arrange the monitoring of the device through the NJR
3. Oversee the performance of the device by arranging appropriate reviews and user group meetings for the implant.
BC and ODEP
If when a manufacturer submits to ODEP for “Pre-Entry” status and their implant has fully completed an agreed a BC assessment, they will be eligible for “Pre-Entry A*”.
Pre-entry is not an ODEP benchmark, it is a signal that an implant has entered the process. “Pre-entry A*” is classified as a benchmark and this means that a hospital is using an ODEP benchmarked implant.