Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

Abstract

Health technologies defined broadly embrace a range of applications of organized knowledge and skills in the form of pharmaceuticals, medical devices, vaccines, medical and surgical procedures, and systems developed to improve health. Within this broad definition, medical devices include a wide-ranging and heterogeneous group of health technologies that are used to diagnose illness, to monitor treatments, to treat acute and chronic illnesses, and to assist disabled people. The European Union (EU) market has over 500,000 types of medical devices. With an estimated market size of roughly €100 billion, medical devices account for about 7.5% of healthcare expenditure in most publicly funded healthcare systems. These technologies are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to policy makers. The challenge is to adopt policies to allow access to safe and effective technologies while providing adequate incentives to the industry to invest in research and development of new products.In the effort to properly address these challenges and overcome the gaps of the past, policy makers in Europe have for years discussed new rules for licensing and market access of medical devices in the EU market. These long discussions resulted in

Coverage with evidence development program on stereotactic body radiotherapy in Belgium (2013–2019): a nationwide registry-based prospective study

“… 4 The EU Horizon 2020 COMED project aimed to optimise the knowledge of and research on the evaluation and diffusion of medical devices. 6 In this context, it analysed the challenges and current status of CEDs for medical devices in Europe, based on systematic literature review and interviews with stakeholders. The work culminated into a set of proposals for a good conduct of CEDs in medical devices, optimally aligning the actual practice in Europe with the economic theory behind CED schemes.…”

“…Postulating that survival is the most final clinical outcome for patient and society, overruling surrogate endpoints such as local control, only survival data were considered by linking the patients’ National Social Security Identification Number to their vital status in the Crossroads Bank for Social Security. 6 This again was a pragmatic approach allowing data collection to be restricted to the moment of registration. This however also translated into the lack of information on subsequent treatments, toxicity or QoL.…”

“… 4 , 5 CED for medical devices has been evaluated in the EU funded COMED project, demonstrating that its use across Europe remains limited and highly variable. 6 , 7 , 8 …”

Assessing medical devices: a qualitative study from the validate perspective

“…Current discussions about appropriate HTA methodology for assessing (high-risk) medical devices show that this is not an easy task. Based on differences between medical devices and drugs, scholars argue that HTA methodology for medical devices should be adapted to 1) integrate other types of evidence (e.g., real-world evidence) to address the lack of evidence from randomized clinical trials and capture the impact of iterative developments of devices on outcomes; 2) broaden the scope of assessments to capture organizational aspects (e.g., impact on healthcare capacity); and 3) involve stakeholders in assessments (e.g., making methodological decisions) to address context-dependence of outcomes and gather information on user experiences and preferences (2)(3)(4)(5)(6)(7)(8).…”

Early technology review: towards an expedited pathway

“…In Europe, the pathway to adoption begins with regulatory approval by the European Union (EU) Medical Device Regulation (MDR) which aims to ensure an acceptable standard of safety and quality for medical devices as well as standardizing data and technological advances through a EU database (EUDAMED) (7). The MDR new rules change the type, quantity, and quality of evidence to be generated by the manufacturers, especially of those producing high-risk technologies that are affected by the MDR (8). The recently approved Regulation EU 2021/2282 policy on health technology assessment (HTAR) (7) aims to improve the availability by EU patients to innovative health technologies including medical devices in part by ensuring an efficient use of resources and strengthening the quality of HTA across the EU.…”