Browsing by Subject "high risk medical device"

The national legislation, based on EU Directive 93/42, has regulated the high-risk medical devices in Europe to this day. It requires that in order to enter the market, the device must be safe, suitable for the intended use and acceptable in performance. The demonstration of clinical efficacy is not required. The information on which clinical evidence is based, is not publicly available, as clinical evaluation data and the results of a clinical trial are not required as a condition of market access in Europe. This has given the opportunity for manufacturers for faster and more cost-effective pathway to bring the medical devices to market in Europe. This has boosted the activity of device industry in Europe. However, the weaknesses of European legislation are considered to be one of the reasons caused the large-scale device scandals (lack of safety and effectiveness) in the early 2000s. As a result, a new EU Regulation 2027/745 on medical devices has been created and will enter into force in all Member States in May 2021. The aim of this study was to create an overview of the clinical evidence on high-risk medical devices marketed in Europe and how the issue has been investigated. A systematic literature review was used as the method in this study. The challenge was that there was lack of material available on the subject in question. This is probably due to the limited availability on clinical information of marketed devices, as a public database (Eudamed) does not exist yet in Europe and the device manufacturer may not publish the results of clinical studies. This issue has been investigated by using some reimbursement assessment decisions could be found from few European countries. The level of clinical evidence of devices in the United States has been extensively investigated. Medical devices marketed in Europe have been submitted for registration to United States, so information on European devices can be found in United States public sources. This information will provide a stronger insight of the level of clinical evidence regarding the devices marketed in Europe and thus the publication has been justified to be included in this study. According to the information obtained from this study, the clinical evidence of high-risk medical devices is mostly incomplete and of poor quality. This has negative effects on physicians making treatment decisions, patients using the devices, as well as device manufacturers. Clinical trial methods do not fully comply with the gold standard and the use of other methods is not clearly justified. The requirements for new devices will be significantly tightened and the clinical evidence of already approved devices will need to be updated due to the new device regulation. Clinical data will be publicly available in Eudamed database in the near future. Guidance from Notified Bodies and Authorities regarding alternative methods for clinical trials expected to be also clarified. New requirements of clinical evidence will increase manufacturer´s costs. It may also be the case that, clinical evidence updates of current devices cannot be implemented from a safety point of view. It is likely that important devices will exit the European market and the industry will suffer. An agreement should be reached together with authorities and industry to ensure self-sufficient European device manufacturing and the promptly availability of vital devices for patients.