Patient safety
promote patient safety, without discouraging manufacturers from bringing ground-breaking new products to market or putting existing products through the regulatory process.5 Registries will be an instrumental part of that balancing act as they can provide the evidence needed for regulators within the new legislative landscape. This is because, unlike a database which is simply a repository for data, a registry is a system which collects and monitors data contemporaneously, that is then analysed regularly and interpreted by medical professionals to evaluate outcomes, with the aim of improving the quality of patient care. In principle, a registry can collect data
on every medical procedure, so each time a surgeon places a joint replacement in a patient, those details are recorded. While there is great advantage in collecting
data through controlled clinical trials, registries are generally cheaper and more comprehensive. They nearly always provide information more quickly, as the cohorts of patients are usually much greater. Data is collected from all surgeons using the device and not just the design surgeon, as is often the case with a trial.
It is also much more cost effective for manufacturers to contribute to a registry than to commission their own research studies, which will encourage innovation, as well as keeping successful devices in the market. Some specialties already have well established and well-guarded device registries, such as the National Vascular Registry (NVR) and the National Joint Registry (NJR). The NJR, delivered on the NEC Registry platform, was established in 2003. Mandatory data collection is the key to building a comprehensive information registry. With complete data sets, registries can provide a full picture of device performance, which can feed into regulatory decision making. Registries can be used to support innovation in the new regulatory landscape as clinicians and manufacturers can use them to gain the insight needed to spot any gaps in current device availability and identify opportunities for further innovation in medical device technology. “We will always need manufacturers
to develop new implants to solve complex individual situations, such as when a patient’s anatomy has changed from the standard situation, or has been damaged and needs complicated revision surgery,” explains John Skinner. “The more data we have on this, the better. But it’s from how that information is interpreted that we learn the most.”8 With the onset of tighter regulations calling on manufacturers to submit data on devices which have been on the market for a long time,
a registry will provide the essential insight needed to report on the performance of a well- established device with a high success rate too. As Tim Wilton, Medical Director of the National
Joint Registry, outlines, “While innovation is vital in many areas of medicine, it’s important to remember that many devices which have been used for years are still performing very well, and registries can provide evidence of this. For instance, many of the hip and knee replacements, which have been available for a long time, are still very good and the chances of making something better are relatively small.”8 By collecting real-world data on device usage
and outcomes, registries provide evidence of the effectiveness of new innovations and are also pivotal in monitoring the quality of existing devices.
Changes to medical device regulations in the UK are still being mapped out. However, it is likely that the new framework will see manufacturers facing a more demanding legislative regime when introducing new products to the UK market. They will also have to demonstrate the effectiveness of their existing devices more comprehensively. Whichever direction the new regulations
take, medical device registries will become an increasingly important mechanism that can be used to reduce regulatory burden and support and foster both safety and innovation.
SCAN ME About the author
Mr Keith Tucker explores these views further in: ‘Medical device regulations: a step forward for patient safety or a step backwards for innovation? How medical device registries can promote both safety and innovation in a new regulatory landscape’.
To download the report, scan the QR code above or visit: https://
nec.e.necsws.com/NEC-Registries- Whitepaper
Mr Keith Tucker, FRCS, is the Chairman of ODEP (Orthopaedic Data Evaluation Panel) and the “Beyond Compliance advisory group”. He is also a member of the Network of Registries of Europe, member of the EFORT working group on dangers of Cobalt in TJR, and a Trustee for the Gwen Fish Trust (a charity). Previously, he has occupied the position of Consultant General Orthopaedic surgeon, at Norwich, and has been the Secretary and President of the British Hip Society. He has also previously chaired the Implant Performance NJR Committee, as well as co-authoring numerous orthopaedic papers and chapters in books. His current areas of research include the use of machine learning in orthopaedics, particularly in Hip Replacement.
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References 1. The Guardian, Thousands of breast implant victims get pay outs after court ruling, 20 May 2021.
2. IMMDS Review Report, First Do No Harm 3. Patient Safety Network Glossary 4. MHRA Regulating Medical Device Regulations in the UK, February 2024 updated.
5. British Orthopaedic Position statement on Medical Device Regulation 2020
6. Maresova P. Impact of Regulatory Changes on Innovations in the Medical Device Industry Comment on “Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper”. Int J Health Policy Manag. 2023;12:7262. doi: 10.34172/ijhpm.2022.7262. Epub 2022 Jun 15. PMID: 35942961; PMCID: PMC10125071.
7. Thomas, Liji. 2022. The Importance of Regulating Medical Devices. News-Medical, viewed 16 February 2024,
8. Medical device regulations: a step forward for patient safety or a step backwards for innovation?’ How medical device registries can promote both safety and innovation in a new regulatory landscape.
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