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The COVID-19 pandemic that has gripped the world since early 2020 has underscored the need for an effective right to repair medical equipment. As healthcare systems have been pushed to the limit, keeping critical medical equipment (such as ventilators) in working order has become a matter of life and death. Unfortunately, the ability of hospitals and other healthcare providers to service and fix their medical equipment is often hindered by the tight control that original equipment manufacturers keep over repair of their products. On top of direct contractual restrictions on repair, one of the major difficulties encountered by hospital-based and third-party service providers is the lack of access to service manuals, service keys, schematics, replacement parts, and repair tools. The ability to block access to these critical items is abetted, in large part, by intellectual property laws. In August 2020, a new federal legislation was introduced to address this problem--the Critical Medical Infrastructure Right-to-Repair Act of 2020 (the "Act"). The Act was designed to facilitate repair of critical medical infrastructure during the current COVID-19 pandemic, and to do so, it addressed various relevant intellectual property issues. Although it failed to pass in 2020, the Act was the first attempt to enact federal repair legislation. Given this, this Article provides a critical analysis of the Act and examines the extent to which it could have served its prescribed goal. In addition, in the event the Act is reintroduced (or similar legislation is introduced) in the coming years, we provide constructive suggestions to improve it. We also investigate the role that courts could play, alongside such legislation, by using policy levers that already exist in intellectual property law to provide relief to hospital-based and independent service technicians and to mandate manufacturers to cooperate with them in certain circumstances. [ABSTRACT FROM AUTHOR]

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An editorial focuses on the proliferation of mobile health applications (MHAs) and the need for ethical and legal safeguards in their development and use.

The article deals with the topic of official liability for faulty administrative action according to the Medical Devices Act (MPG) in Austria. It is pointed out that according to § 1 of the Official Liability Act (AHG), local authorities as well as other legal entities of public law are liable for damages caused unlawfully and culpably. It is emphasized that even in the case of omission, claims for damages can be made if there is a corresponding obligation to take action. The article clarifies that the MPG 1996 and the new MPG 2021 aim to prevent harm to patients, users, and third parties. It is noted that the Federal Office for Safety in Health Care is responsible for the control of medical devices and claims for official liability can be made if it fails to fulfill its legal mandate adequately. It is expected that the decision of the Supreme Court (OGH) will also apply to the new MPG 2021. It is pointed out that the new MPG 2021 does not provide for any provisions for exemption from liability or limitation of liability according to the AHG. [Extracted from the article]

The images in the American Medical Association's Historic Health Fraud and Alternative Medicine Collection include quack devices from the early 20th century, which gave rise to regulatory and professional oversight. [ABSTRACT FROM AUTHOR]

This article examines the history of device oversight by the US Food and Drug Administration (FDA). Significant regulatory changes occurred in response to injuries caused by Dalkon Shield intrauterine devices. This article summarizes those changes as well as continued efforts by the FDA to strengthen device oversight and address areas of concern. [ABSTRACT FROM AUTHOR]

The authors aim to familiarize the reader with the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED) and the agency's perspective regarding the development and implementation of regulatory sciences as an interactive tool to promote cooperation and scientific thinking. The authors share their viewpoint on the preparedness of Latin American regulatory agencies by assessing innovation (i.e. novel biopharmaceuticals, vaccines, etc.), analyzing the challenges which are impacting healthcare and patients, and posing suggestions for a collaborative regional and international approach. To conclude, the authors' share recommendations for the implementation of regional initiatives aimed at supporting regulatory science, with the goal to promote the exchange of scientific cooperation as a vital element to maximize regulatory skills and competencies. [ABSTRACT FROM AUTHOR]

Background Open do- it- yourself (DIY) health innovations raise new dilemmas for patient- oriented and service- oriented scholars and healthcare providers. Our study aimed to generate practical insights into quality and safety issues to patient care raised by two volunteer- run, open DIY solutions: Nightscout Project (patient- driven, open- source software for type 1 diabetes management) and e- NABLE (volunteers who design and three- dimensionally print upper- limb assistive devices). To this end, we examined the views of health innovators who are knowledgeable about medical devices standards and regulations. Methods We applied a multimedia- based, dataelicitation technique to conduct indepth interviews with a diversified sample of 31 health innovators practising in two Canadian provinces (Quebec and Ontario). An exploratory thematic analysis approach was used to identify respondents' reasoning processes and compare their overall judgements of Nightscout and e- NABLE. Results Respondents pondered the following quality and safety issues: importance of the need addressed; accessibility; volunteers' ability to develop and maintain a safe solution of good quality; risks involved for users; consequences of not using the solution; and liability. Overall, innovators see Nightscout as a high- risk DIY solution that requires expert involvement and e- NABLE as a low- risk one that fills a hard- to- meet gap. Conclusion Health innovators generally support patient- driven initiatives but also call for the involvement of professionals who possess complementary skills and knowledge. Our findings provide a list of issues healthcare providers may discuss with patients during clinical consultations to document potential risks and benefits of open DIY solutions. To inform new policy approaches, we propose the development of publicly funded umbrella organisations to act as intermediaries between open DIY solutions and regulatory bodies to help them meet quality and safety standards. [ABSTRACT FROM AUTHOR]

Importance: US law generally requires testing of high-risk medical devices prior to approval, as well as premarket evaluation of moderate-risk medical devices, with the goal of ensuring that the benefits of these products exceed their risks. The US Food and Drug Administration (FDA) attempts to balance the need for evidence generation with an approval process that facilitates access and encourages innovation.Objective: To review the development of laws and standards affecting the evaluation and oversight of medical devices by the US regulatory system and the outcomes of this system from 1976 to 2020.Evidence Review: Laws enacted by US Congress and regulations promulgated by the FDA through 2020; databases maintained by the FDA of device authorizations from 1976 to 2020; and annual reports of user fees paid to the FDA by industry.Findings: Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user fees. From 1987 to 2020, the annual number of novel devices granted premarket approval (which excludes supplements) ranged from 8 to 56 (median, 32), and the number of clearances for 510(k) devices (those that are "substantially equivalent" to marketed devices) ranged from 2804 to 5762 (median, 3404). User fee funding for devices was established in 2002 and annual fees collected increased from $30 million in 2003 (in 2019 dollars) to more than $208 million in 2019; this represented 43% of FDA funding related to the review of medical devices. Although many new devices have led to considerable patient benefit, such as hypodermic needles and magnetic resonance imaging machines, important adverse events caused by some devices, such as an implanted device for birth control and a surgical mesh implant for pelvic organ prolapse, have led to calls to reexamine the regulatory system for such products.Conclusions and Relevance: Over the last 45 years, medical device regulation has become more complex, with more regulatory pathways and greater variations in the evidence and controls required for authorization. Increased FDA support from industry and concern about flexible authorization requirements reflect the tension between efficient access and the need for assurances that products will safely benefit patients. [ABSTRACT FROM AUTHOR]

The use of ionising radiation for plain film radiography and computerised tomography is fundamental in both diagnostics and treatment for orthopaedics. However, radiation is not without risk as high exposure can increase the risk of cancer. Little time is spent educating doctors about the relative risks of radiation, both to patients and themselves. In addition, there are common misunderstandings about the best ways to mitigate such risk. We aim to provide an overview of the fundamental principles of the use of ionising radiation and its risks within the context of orthopaedic surgery. While providing a narrative review of the current literature, we discuss the basic physics, standards of good practice and relevant UK and European regulations. We discuss the risks to patients and surgeons and suggest ways that these can be mitigated in the operating theatre. A thorough understanding of the risks, and appropriate procedural rules, with respect to the use of ionising radiation is essential for those in orthopaedic practice. [ABSTRACT FROM AUTHOR]

Background: To promote the efficiency and quality of registration for medical products, the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) has implemented a 2020 roadmap to promote the concept of GRM since 2011. Key outcomes of this roadmap are discussed in this article to provide recommendations for improved regulatory practices and accelerated regulatory convergence. Methods: Adoption of relevant guidelines and delivery of training programs from the APEC Training Centers of Excellence for Regulatory Science (CoEs) have played a key role to promote capacity building, cooperation and convergence in good review practices (GRevPs) and good submission practices (GSubPs) for medical products among APEC economies. A key performance indicator (KPI) survey among the drug regulatory authorities (RAs) of APEC economies was conducted to understand the progress of this roadmap. Results: The CoE programs have provided a unique opportunity to promote dialogues between regulatory authorities and industry and efficiently disseminated the concept of GRM among APEC economies. The results of the KPI survey indicated significant progress in the status of implementing GRevPs over the last ten years. Conclusions: To accelerate regulatory convergence among APEC economies, it is necessary to promote mutual trust and cooperation in approval of medical products over the time. Continuous training in GRevPs and GSubPs through the CoE platform would set the stage to achieve the goal in the next decade. [ABSTRACT FROM AUTHOR]

Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods: The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19. [ABSTRACT FROM AUTHOR]

Background: The UK's transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. Methods: A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. Results: Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for "pay for performance" products; and education and professional development. Conclusions: The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients' experiences and perspectives, and investing in a skilled workforce. [ABSTRACT FROM AUTHOR]

Background The integration of new technologies can call for obeying different rules and should be considered a long-term evolutionary process that is realised step by step. Before a medical device appears in the market, a long regulatory process has been completed, including safety, experimental and preclinical studies leading to an authorisation for distribution in a national market. Depending on the target countries and their respective regulations, the need for robust clinical studies, including randomised clinical trials, is often mandatory for distribution. Post-clinical trials may be used to confirm the results obtained from a medical device. The efficacy of the introduction of new technology in daily practice is then dependent on clinicians' perceptions of the improvement in wound-healing. Complications may occur even after a long period of time, with severe consequences for patients' quality of life. Since the PIP (Poly Implant Prothèse) scandal, more restrictions have been imposed to prevent such failures and increase the safety for the population. [ABSTRACT FROM AUTHOR]

The article offers insight to new Medical Devices Ordinance (MDR) which is intended to ensure that manufacturers and users of medical devices are protected from possible health effects and that they comply with various regulations when handling the products. Topics include making products available on the market and putting products into service; identification and traceability of products; and classification and conformity assessment.

The article offers information on the Central Drugs and Standards Control Organization (CDSCO) and the Bureau of Indian Standards (BIS) reviewing safety standards for lifesaving medical devices to make them more stringent.

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed. [ABSTRACT FROM AUTHOR]

Japan's rapidly aging population has prompted a change in the country's pharmaceutical care framework from a drug-oriented to a patient-oriented approach. Pharmacies and pharmacists are expected to play central roles in this new patient-oriented approach by reconciling medication and managing polypharmacy, conducting home visits, and providing care to patients in collaboration with local clinics and hospitals. These additional roles are expected to lead to a reduction in the prevalence of adverse effects and improve the quality of life of patients in Japan's aging society. To promote patient-oriented care by pharmacists, these additional roles were legislated in a revision of the Japanese Pharmaceutical and Medical Device Act and other related Act in December 2019. Here, we overview how the revisions affect pharmacies, pharmacists, medical institutions, and outpatients. [ABSTRACT FROM AUTHOR]

The article provides an overview of Medical Device Regulation for manufacturers, users and dealers in Germany. It mentions that , it is intended to ensure that manufacturers and users of medical products are protected from possible health effects and that they comply with various regulations when handling the products.

Policy PointsMillions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers.Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device‐collected data.Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Context: Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Whether patients have either legal or normative claims to data collected by these devices, particularly in the raw, granular format beyond that summarized in their medical records, remains incompletely explored. Methods: Using pacemakers and implantable cardioverter‐defibrillators (ICDs) as a clinical model, we outline the clinical ecosystem of data collection, relay, retrieval, and documentation. We consider the legal implications of US and European privacy regulations for patient access to either summary or raw device data. Lastly, we evaluate ethical arguments for or against providing patients access to data beyond the summaries presented in medical records. Findings: Our analysis of applicable health privacy laws indicates that US patients may have little access to their raw data collected and held by device manufacturers in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation (GDPR) grants greater access to device‐collected data when the processing of personal data falls under the GDPR's territorial scope. The California Consumer Privacy Act, the "little sister" of the GDPR, also grants greater rights to California residents. By contrast, our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices. Smartphone applications are increasingly involved in the collection, relay, retrieval, and documentation of these data. Therefore, we argue that smartphone user agreements are an emerging but potentially underutilized opportunity for clarifying both legal and ethical claims for device‐derived data. Conclusions: Current health privacy legislation incompletely supports patients' normative claims for access to digital health data. [ABSTRACT FROM AUTHOR]

The article informs about Neolithic dentists using drills made from flint heads were active in Pakistan as all medical devices have greatly transformed the quality of our lives, facilitating the lengthening of the life span. Topics include applicable essential technical requirements as published in either the European directives or regulations; and manufacturing premises to increase the likelihood of detecting any suspicious activities.

Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) (EU 2017/745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective. [ABSTRACT FROM AUTHOR]

The first documented mention of a needlestick injury (NSI) in the medical literature appeared in 1906. Despite growth in academic and clinical interest for NSI prevention, a global report identified that approximately 3 million healthcare workers have suffered percutaneous exposure to blood-borne pathogens. Legislation is an important component of NSI prevention. Unfortunately, the impact of legislation may not always reduce the incidence of NSI as much as expected. Safety-engineered device (SED) implementation has demonstrated a substantial reduction in NSI rates compared with non-SEDs. More importantly, passive SEDs are 10 times less likely to be connected with an NSI incident [ABSTRACT FROM AUTHOR]

The article highlights to present WHO Member States with widely-recognized principles of Good Regulatory Practices (GRP). It discusses principles which are presented derive from an extensive review of public documents developed by governments and multi-lateral organizations which includes legality, consistency, independence, impartiality, proportionality, flexibility, clarity, efficiency and transparency, relevant to all authorities responsible for the regulatory oversight of medical products.

Given the increasing availability of large data set, small single-institutional series raise decreasing attention. Rapid expansion of technology from electronic medical records to easily accessible internet access, and widespread use and acceptance of registries in the medical world has allowed for research and quality improvement efforts using 'big data'. Big data, although technically not defined, typically refers to large databases that can be used to investigate common or rare disease processes or outcomes, describe variation in clinical practices across and between different specialties at various practice location, whilst allowing important information about trends over time. Big data have allowed investigators to quickly assimilate cohorts of patients and/or procedures to answer current questions, with more complete population representation and improved generalizability whilst decreasing the likelihood of power problems and type II errors. On the other hand, pitfalls still exist with the growing problem of hypothesis fishing, lack of granularity and the fear by many clinicians that registry transparency may have already gone too far, where surgery groups or individual surgeon outcomes are readily available to patients and referring providers. Within vascular surgery specifically, big data have expanded over the last decade and now includes regional, national and global registries that have major benefits of gathering specific clinical and procedural information within vascular surgery. In this review, we highlight the main vascular surgery registries and recap a few success stories of how the registries have been leveraged to benefit discovery, quality improvement and ultimately patient care. Additionally, we outline future directions that will be imperative for continued expansion, acceptance and adoption of 'big data' utilization inpatients with vascular disease. [ABSTRACT FROM AUTHOR]

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data. [ABSTRACT FROM AUTHOR]

Background: FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Methods: Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA's public database. Results: Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. Conclusion: As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products. [ABSTRACT FROM AUTHOR]

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), "intended" clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients' well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer's understanding of their device's clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits. [ABSTRACT FROM AUTHOR]

In May 2017 the European Medical Device Regulation (MDR) was published to replace the current Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD). After a transition period of 3 years (ending May 2020) the MDR will apply in the European Union (EU). With this new legislative framework, the requirements for placing new medical devices and keeping existing medical devices on the EU market will become more stringent. This is mainly due to the focus on clinical data for all medical devices regardless of their classification and the increased requirements on the post market surveillance system. In most cases, the MDR will require pre-market clinical studies for implantable medical devices and devices falling in the highest risk class (Class III). Since 2000 there has been a significant increase in the quantity and quality of publications in the fields of orthopaedic and orthopaedic trauma surgery. However, there is still a large number of medical devices without direct clinical data which rely on market experience and the established level of a specific technology or a group of devices. Due to this fact, and the fact that the new MDR is requiring sufficient clinical data for devices which shall stay on the market after May 2020, there is an increasing need for new clinical data sources reflecting the real-world use of medical devices. [ABSTRACT FROM AUTHOR]

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

Background: Up until 2017, medical devices were placed on the European Union's (EU) single market in accordance with either Medical Device Directive 93/42/EEC for general medical devices or Medical Device Directive 90/385/EEC for active implantable devices. However, some devices that complied with these directives still failed catastrophically. In the orthopaedic device field, these failures were most pronounced in metal-on-metal hip devices causing severe patient morbidity with increased need for revision surgery which had unpredictable outcomes. Subsequently, the newly introduced Medical Device Regulations 2017/745 are aimed at addressing patient safety based on previous experience and thorough device assessment prior to and post-release on the EU single market; to accommodate for this they are substantially different (and more stringent). This poses a greater challenge for manufacturers and regulatory bodies in terms of time and resources. Methods: A review of the EU directives and published literature was undertaken. This review provides the rationale behind this change and its potential impact on research, industry, and clinical practice. Discussion: The change in legal requirements for the medical devices to be put on the EU single market ultimately leads to increased patient safety, which is supported by clinical professionals. The new requirements for data transparency, post-market surveillance, and implant information availability increase the chance of catastrophic failure prevention. However, the exact method of implementation remains uncertain, and some essential rules on the data requirements for compliance have not yet been published by the EU. These limitations may limit the availability of products on the market including withdrawal of existing devices and a decrease in new medical device innovation. It is speculated that lack of new technologies within the medical device area can dramatically affect patient safety itself by not allowing potentially safer materials and methods on the EU single market, as the focus for the manufacturer becomes existing devices. [ABSTRACT FROM AUTHOR]

Purpose: According to the importance of strategic purchasing as an effective tool for resource allocation and service procurement, this study examines national laws, regulations and other related documents related to the strategic purchasing of health services related to the advanced medical equipment in Iran. Design/methodolgy/approach: It was a national qualitative document analysis conducted in 2019 applying content analysis approach. The four-step Scott method was used to include the documents in terms of authenticity, credibility, representation and meaningfulness. After retrieving the related documents, they were coded with the implicit and explicit approach. MAXQDA10 was used for content analysis. Findings: The findings show that according to the framework of effective factors on the strategic purchasing of health services, seven main factors are determined as the main essential factors in purchasing advanced medical equipment. These factors consist of health care providers, health service buyers, purchaser and service provider contracts, payment mechanisms, organization and management evaluation of health technology including expensive medical equipment and technology-related. Research limitation/implication: The study had some limitations as follows: the proposed method should be tested and its feasibility has to be investigated through appropriate tools for Iranian insurance companies and those with the similar settings. Practical implication: The results of this study can shed more light for policy makers affiliated in Ministry of Health as the main service provider, Ministry of Welfare and the insurance agencies as the main purchasers of health services on paying attention to these seven main themes extracted from the upstream documents and laws and regulations of the Islamic Republic of Iran. Social implication: The strategic purchasing of expensive high technology-based medical equipment is a necessity for Iranian public health insurance organizations that is emphasized in national documents in the way of implementing this necessity. Originality/value: This study examines all the laws and regulations and all related documents in the strategic purchasing of health services related to advanced medical equipment, giving an analysis of the most important challenges and requirements of implementing strategic purchasing in the health services provision sector with expensive medical equipment. [ABSTRACT FROM AUTHOR]

Problem Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India. Approach Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority. Local setting Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme. Relevant changes From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting. Lessons learnt Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting. [ABSTRACT FROM AUTHOR]

The article offers information related to the implications of Medical Device Regulation (MDR) for the economic operator. It mentions about the changes introduced by MDR for economic operators including medical device identification system changes with the incorporation of a Unique Device Identifier; and need of additional documentation obligations due to new class III devices.

Background: In evaluating 3 or more comparators, pharmacoeconomic analyses can be improved by using the methodology of net monetary benefit (NMB) as opposed to incremental cost-effectiveness ratio (ICER). NMB is particularly suitable for managing competitive tenders that evaluate 3 or more devices in the same lot. For scientific purposes, the methodology of NMB is perfectly adequate. However, when tenders are managed in European countries, the Public Procurement Directive states that the tender score for price should be kept separate from that of clinical benefits. As a result, the traditional mathematical approach of NMB must be rearranged to comply with this administrative requirement. Methods: In this report, we describe how the classic equations of NMB should be modified to achieve this purpose. The mathematical principle of proportionality, which is typical of the ICER, must be replaced by the principle of mathematical additivity, which is typical of NMB. Furthermore, to rearrange the scale of benefits according to the NMB, an estimate is needed of the minimum acceptable benefit converted into monetary units, which is associated with 0 in the benefit scale. Results: A detailed example is presented to explain the practical application of these mathematical equations. These equations are widely applicable in the field of implantable devices. Conclusion: Since the expenditure for medical devices in European hospitals is close to that of hospital medicines, tenders for the in-hospital procurement of devices may represent a decisive tool to manage sustainability and ensure access to innovation. In this context, the methodology for managing clinical outcomes through tenders requires a specific mathematical approach that we have described in the present article. [ABSTRACT FROM AUTHOR]

We study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare. Product testing can reduce consumer uncertainty, but also increase entry costs and delay entry. Using variation between EU and US medical device regulations, we document patterns consistent with valuable learning from more stringent US requirements. To derive welfare implications, we pair the data with a model of supply, demand, and testing regulation. US policy is indistinguishable from the policy that maximizes total surplus in our estimated model, while the European Union could benefit from more testing. "Post-market surveillance" could further increase surplus. (JEL D43, I18, L13, L51, L64, O31, O38) [ABSTRACT FROM AUTHOR]