BACKGROUND: The MDD (Medical Device Directive 93/42/EEC) and AIMD (Active Implantable Medical Device Directive 90/385/EEC) have been repealed and replaced by MDR 2017/745. MDR 2017/745 places a significant regulatory and financial burden on medical device manufacturers as they strive to meet the new requirements. In contrast to the US regulatory scheme there are no provisions for grandfathering products certified under the previous Directives. The purpose of this research was to identify, define and describe the regulatory burden of Regulation 2017/745 placed on manufacturers of legacy implantable, intra-articular medical devices for treatment of Osteoarthritis and the potential impact of market shortages as manufacturers strive to comply. Osteoarthritis is a disease occurring mainly in adults over 50 years of age and results in reduced quality of life. Osteoarthritis is a disorder of synovial joints. Some complications of the disease include difficulty walking, performing day-to-day tasks, chronic pain and mental health issues resulting from the physical challenges and pain suffered by patients. Legacy implantable intra-articular devices such as Durolane®, Hyalgan® and Synvisc® have been available on the European market under the Medical Device Directive 93/42/EEC. Literature indicates the product is a valuable treatment option for patients in terms of efficacy and cost and contribute to an improved quality of life for Osteoarthritis sufferers.

METHODS: This research explores the difficulties encountered by manufacturers as they strive to comply and also the potential knock-on effect for patients and Health Care Practitioners in the event products are in short supply. Information was collected in the form of a survey and interviews with experts. A questionnaire was developed using Microsoft Teams Form, issued to colleagues, and disseminated via LinkedIn. The data collected is qualitative and quantitative in nature and was analysed using thematic analysis and statistics. The surveys were targeted at professionals within the medical device industry to gather information on how MDR has impacted businesses specifically in clinical evaluation. Semistructured, recorded interviews were conducted with Clinicians, Pharmacists and Marketing personnel to understand the impact a market shortage would have on patients.

FINDINGS: Data to comply with MDR clinical requirements is being sourced almost equally from literature searches, clinical investigations, and post market sources. Respondents agree that clinical evaluation requirements are well-expressed in guidance documents. Clinical evidence gathered for devices under MDD is lacking, resulting in revisions to intended purpose, indication statements and associated clinical benefits of the device(s), the conditions of use, specific contraindications, and risk management files. A third of surveyed manufacturers expect a decrease in patients accessing the device and 50% expect a reduction in sales. For patients, a market shortage will impact those who are ineligible for NSAIDs and have exhausted other therapeutic options.

CONCLUSIONS: As a result of the cost to organisations in terms of resources needed to meet MDR requirements and potential for loss of sales, the MDR places a manufacturer in an unfavourable financial position. Manufacturers may withdraw products from the EU market. The knock-on effect for patients using intra-articular medical devices for Osteoarthritis treatment will be of significance for those who are ineligible for NSAIDs when physical therapy, basic pharmacological treatment, and first-line joint injection with corticosteroid have not given adequate relief. MDR may also be presenting a barrier to newer therapies such as PRP, both primary and secondary research has shown that although there is interest from the medical profession, there is little clinical data available. At the end of the transition period for Class III implantable intra-articular devices, May 2027, we may see a decline in these products available on the EU market and a delay in innovative products reaching the market. Considering the prevalence of OA within society, the impact of the MDR may be significant for patients.