Professor Simon Donell BSc FRCS(Orth) MDConsultant Orthopaedic Surgeon Norfolk & Norwich University HospitalHonorary Professor University of East AngliaPresident British Association for Surgery of the Knee (BASK)
Regulatory approvals for medical devices are governed by EU and UK law (Medical Devices Regulations 2002 (as amended) issued under the Consumer Protection Act 1987). EU regulations apply directly to the UK and do not need to be transposed. The obligations on manufacturers are to ensure their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EU member state. To obtain a CE mark the manufacturer submits a dossier to the relevant Notified Body that describes the device and its intended use and defines any variants. If the device is part of a “family” (typical for knee replacements) the rationale for this has to be outlined from the point-of-view of design, technology, and functionality. The product or family conforms by verifying the conclusions of the risk analysis, all applicable essential requirements have been addressed, relevant applied, and the conclusions of the clinical data.
To introduce a new joint replacement in the UK involves a pathway of regulatory approvals through the National Joint Registry (NJR), the Orthopaedic Data Evaluation Panel (ODEP) and the Medicine and Healthcare Products Regulatory Agency (MHRA). The company registers the device, submits the supporting data and moves towards the 10-A benchmark through pre-entry, 3-, 7-, and 10-year benchmarking by ODEP.
Beyond Compliance is an initiative that is voluntary and goes beyond the normal regulatory approvals. It has to be voluntary to avoid problems with the competition laws of the EU. It aims to provide the manufacturer with post-marketing surveillance and help with iterative designs, as well as novel devices. This is supported by the UK government through its aim to increase manufacturing to boost the economy. In 2011 £5 billion was generated through the manufacture of single-use devices, wound management devices, orthopaedics implants and professional services. Beyond Compliance is about accelerating gaining regulatory approvals for innovative products to obtain better patient care and quality-of-life, and decreasing costs to the NHS (the National Health Service—the state-financed healthcare provider in England and Wales). It should also halt failing products earlier to the benefit of all.
Beyond Compliance will help manufacturers by giving advice on setting up post-marketing surveillance, commenting on proposed post-market clinical follow-up studies as part of post-market surveillance, and offering advice on the clinical outcomes to be met (such as duration of follow-up, additional tests, and timelines). Ideally, entry of the device should start before CE marking to help with submission of data to the Notified Bodies and provide an independent data monitoring service. It will provide post-marketing clinical follow-up data on new products (collected via the National Joint Registery), analysis and assessment of individual adverse events, scan for early signals of possible problems and advising on consequent actions, and provide regular feedback to both manufacturers and participating clinicians about how the device is handling across the whole patient cohort.
Advice to industry and/or the Notified Bodies will include aspects of clinical investigations on new and innovative products, the methodologies for a clinical investigation plan including numbers, aims and objectives, end points, and the centres (and clinicians) which might carry out clinical investigations.
The inclusion criteria are:
l first time use in the UK;
l production of implant new to manufacturer;
l alteration in fixation, working or bearing surfaces;
l change to the materials used;
l and any major design change.
Beyond Compliance has a steering committee that is composed of a chairman and vice-chairman, with representatives from the British Orthopaedic Association (BOA), British Hip Society (BHS), British Association for Surgery of the Knee (BASK), Association of British Healthcare Industries (ABHI), MHRA, Department of Health, Notified Bodies, NHS Supply Chain, and the National Joint Registry. Currently it is in a pilot phase. The legal basis is currently being worked through. Representatives of the ABHI are concerned because the initiative is resourced by NHS Supply Chain. They see a conflict of interest since NHS Supply Chain is involved in implant purchasing. Structures are easy to put in place to exclude NHS Supply Chain seeing any confidential information. Since the initiative is aimed at improving the patient’s lot and protecting them from harm, the onus is on all parties to resolve this.
Currently the regulatory approvals to get a new medical device on to the market are complex, resource intensive and time-consuming. However innovation is good for patients and the economy. Beyond Compliance is an initiative aimed at helping both patients and industry. It is a win-win for all parties.
Professor Simon Donell BSc FRCS(Orth) MD
Consultant Orthopaedic Surgeon Norfolk & Norwich University Hospital
Honorary Professor University of East Anglia
President British Association for Surgery of the Knee (BASK)
Professor Peter Kay M.B. Ch,B. BA. FRCS(G), FRCS(Eng).
Consultant Hip and Knee Surgeon Wrightington Hospital, UK.
Clinical Professor of Orthopaedic Surgery Manchester University.
National Clinical Director Musculoskeletal Services (NHS England)
Medical Plastics News would like to credit the UK’s Healthcare and Medicines Knowledge Transfer Network (KTN) for the professional introduction to Simon Donell.