[Medical devices industry: the problem of clinical evaluation reports]. / L'industrie des dispositifs médicaux : la problématique des rapports d'évaluation clinique.

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.

Building a cloud-based data sharing model for the Saudi national registry for implantable medical devices: Results of a readiness assessment.

BACKGROUND: Implantable medical device registries are used as a medium to conduct post-marketing surveillance. Little information is available on the development and implementation of implantable biomedical device registries in general and specifically in Saudi Arabia and the Middle East. OBJECTIVES: This study presents the experiences of building an implantable medical device registry in the Kingdom of Saudi Arabia. The work specifically addresses the early experiences of the Saudi Food and Drug Authority in the planning and development of a data sharing model for the implementation of a medical device registry at different hospital sites within the country. METHODS: A two-year case study in which 60 health professionals from 5 hospitals in Saudi Arabia participated in a readiness assessment survey. The readiness assessment examined system-level capacity, hospital workflow and operations, clinical staff-level engagement, and technological assessment as they relate to the implementation of the Implantable Medical Device Registry (IMDR). Both subjective and objective data were collected as part of the readiness assessment survey at each hospital site. Data was collected from participants either individually or as part of a group at each hospital site. Using Microsoft Excel, Microsoft Word, flip charts, and back-and-forth discussion, the data was descriptively summarized and synthesized to provide an overview of hospital readiness for IMDR implementation. RESULTS: Results show that there are large differences among Saudi hospitals in terms of their readiness for IMDR implementation due to a variety of factors relating to differences in hospital-wide organizational systems, clinical practice, technological infrastructure, and data sharing capabilities. Each of the hospitals surveyed in this study had differences in how clinical biomedical implantation policies and procedures were utilized. Manual entry into the cloud-based IMDR was recommended as the most optimal data sharing model that would mitigate the differences between hospital readiness for IMDR implementation. CONCLUSION: Registries play a major role in monitoring the effectiveness of implantable biomedical devices. National standardized policies, enforced regulations, and information technology infrastructure are needed to achieve this goal. Furthermore, due to differences in hospital readiness, building a cloud-based registry system through manual data entry into the IMDR was found to be the most appropriate data sharing model that can be implemented at the national level.

Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific.

Asia-Pacific is a region of fast growing opportunity for biomedical research and marketing of new health products by pharmaceutical and medical device companies. While national regulatory authorities have the responsibility to ensure timely access to innovative, effective, and safe therapies, many face capacity and resource constraints that limit their ability to guarantee a robust regulatory system capable of licensing and monitoring novel medicines and medical devices, and tackling substandard and falsified products. The region's regulatory landscape is also fragmented with country-specific requirements that create barriers to entry for new health products. To help address these challenges, the Duke-National University of Singapore's (Duke-NUS) Centre of Regulatory Excellence (CoRE) was established in 2014 with the strategic goals to strengthen the region's regulatory agencies through capacity development, regulatory convergence, work sharing, and nurturing networks for leadership and systems innovation. A smart and mature regulatory system in Asia-Pacific is pivotal to promote biomedical innovation and enhance equitable, sustainable access of populations to quality health products that are safe and efficacious.

[In search of a travel guide-results from a survey of E­health startup companies]. / Reiseführer gesucht ­ Ergebnisse einer Umfrage bei E­Health-Start-ups.

As is the case in other sectors, innovative digital products have started to enter the health market, too. If digital products like apps are considered medical devices, startups are often confronted with regulatory procedures that they deem to be slow and with which they are not familiar. This applies to both the certification procedures and the requirements and procedures for reimbursement, where problems could occur. The aim of this article is to better understand the startups' experience in navigating through these procedures, the hurdles they encounter, and their need for support. Therefore, the digital association Bitkom e. V. and the Federal Institute for Drugs and Medical Devices (BfArM) conducted a web-based survey on five themes with a total of 23 questions. These questions focused inter alia on the composition of the team, product planning, familiarity with regulatory requirements, experience with institutions and different sources of information, the assessment of challenges in the process, and the resulting need for support.The analysis on the basis of 18 complete replies has shown that startups work on products with documentation and communications functions, but also integrate diagnostic and therapeutic features. The latter are characteristics of medical devices. Startups consider themselves to be relatively familiar with regulatory requirements regarding medical devices. The largest hurdles are associated with reimbursement: long and costly processes until the startups' products could be reimbursed.Both with regard to reimbursement and certification, startups see a need for low-threshold, cost-efficient advisory services and a simplification and acceleration of existing procedures with regard to medical devices.

[Medical Devices Law for pain therapists]. / Medizinprodukterecht für Schmerztherapeuten.

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

A study of medical device regulation management model in Asia.

INTRODUCTION: With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. AREAS COVERED: The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.

Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work.

Medical device evaluation presents several unique challenges due to the great diversity and complexity of medical devices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the Medical Device National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medical device registry and post-market surveillance system in Saudi Arabia.

Legal and regulatory challenges currently facing diabetes treatment providers and related durable medical equipment suppliers.

It has been estimated that 24 million Americans have diabetes, many of whom are Medicare beneficiaries. These individuals carefully monitor their blood glucose levels primarily through the use of in-home blood glucose testing kits. Although the test is relatively simple, the cumulative expense of providing glucose test strips and lancets to patients is ever increasing, both to the Medicare program and to uninsured individuals who must pay out-of-pocket for these testing supplies. This article discusses the diabetes durable medical equipment (DME) coverage under Part B Medicare, the establishment and role of DME Medicare administrative contractors, and national and local coverage requirements for diabetes DME suppliers. This article also discusses the federal government's ongoing concerns regarding the improper billing of diabetes testing supplies. To protect the Medicare Trust Fund, the federal government has contracted with multiple private entities to conduct reviews and audits of questionable Medicare claims. These private sector contractors have conducted unannounced site visits of DME supplier offices, interviewed patients and their families, placed suppliers on prepayment review, and conducted extensive postpayment audits of prior paid Medicare claims. In more egregious administrative cases, Medicare contractors have recommended that problematic providers and/or DME suppliers have their Medicare numbers suspended or, in some instances, revoked. More serious infractions can lead to civil or criminal liability. In the final part of this article, we will examine the future of enforcement efforts by law enforcement and Medicare contractors and the importance of understanding and complying with federal laws when ordering and supplying diabetes testing strips and lancets.