Device Regulation Research Articles

Leveraging stringency and lifecycle thinking to advance environmental sustainability in health technology regulation

Abstract Regulatory actors, particularly market authorization agencies, health technology assessment agencies, and health care procurement agencies, exert a powerful influence on the adoption and use of health technologies (eg, medicines and medical devices). With health care being responsible, directly and indirectly, for an estimated 4.6% of global greenhouse gas emissions, alongside other environmental harms, these actors have recognized the need to address the environmental impacts of health technologies. In this commentary, we utilize concepts of regulatory stringency and lifecycle thinking, considering scope, prescriptiveness, and performance requirements, to analyze recent efforts to incorporate environmental sustainability into the regulation of medicines and medical devices. While we acknowledge recent progress, we argue that there is significant, untapped potential for developing more fulsome and effective regulatory mechanisms to improve the environmental sustainability of health technologies.

Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization.

The medical device industry has experienced a significant upsurge in the number, diversity, and complexity of devices over the last two decades. As the global demand for medical devices grows, regulatory frameworks across major economies, including the USA, Europe, India, China, and Australia, have evolved to ensure safety, quality, and efficacy. This review critically examines the regulatory guidelines for medical devices across these regions, emphasizing the need for harmonization to streamline approval processes and reduce regulatory barriers. While countries like the USA and Europe have well-established regulatory systems-such as the Food and Drug Authority (FDA) and European Medicines Agency (EMA)-other nations, including India, are rapidly advancing their frameworks, as seen with the introduction of the Indian Medical Device Rules, 2017, and subsequent amendments. Global initiatives, such as the Global Harmonization Task Force (GHTF), Central Drug Standard Control Organisation (CDSCO), EU Medical Device Regulations (MDR), In Vitro Diagnostic Regulation (IVDR), and the International Medical Device Regulators Forum (IMDRF), have made strides in fostering collaboration, yet disparities remain. Harmonized regulations would mitigate challenges related to device registration, manufacturing, and post-market surveillance, expediting access to high-quality, safe medical devices. The review also highlights the growing prevalence of drug-device combination products, their regulatory complexities, and the importance of aligning regulatory practices globally. A harmonized regulatory framework is essential to promote innovation, reduce duplication of work, and ensure the timely availability of medical devices to patients in need. This review explores the evolution of medical devices from ancient practices to modern technologies, emphasizing projected market growth and the need for regulatory harmonization to facilitate innovation and access. It also assesses how emerging technologies are shaping future regulatory frameworks.

Adjustmentalisation - digitalisation as transformation process and the interplay between a digital logic and diverse primary care logics in Sweden.

This study aims to contribute with knowledge on the characteristics of the process of co-existence of value conflicts between managers, markets/businesses, patients, professionals and digital technology in primary care practices, to be able to nuance the array of descriptions of the consequences of introducing a digitalised care practice, such as telemedicine, into an already existing primary care organisation. Due to its organisational structure and dynamic environment with a multitude of professions and patients as well as influenced by managerial and market drivers, the primary care setting provides fertile ground for studying value conflicts from an institutional logic perspective. This multi-source study utilises qualitative thematic content analysis on empirical data collected through interviews, a survey and documents, followed by an iterative analysis in regard to institutional logics based on the themes developed from empirical data. Coexistence and Adaptation: Different logics coexist and transform through adjustmentalisation rather than competing or dominating each other. Digital Technology's Influence: Digital technology influences and interacts with all established logics, potentially acting as a separate, evolving logic. Changing Healthcare Conditions: New conditions and digital solutions in healthcare may shift the balance of logics, potentially normalising managerial and market logics. Patient Empowerment and Data Ownership: Increasing emphasis on patient empowerment and transparent data processing under regulations like General Data Protection Regulation (GDPR) and Medical Devices Regulation (MDR). With its qualitative design there is not an emphasis on generalisability. The study is performed in a Swedish primary care setting. Regarding its practical implications, this study examines digitalisation and the introduction of eHealth solutions in primary care in Sweden. The adjustmentalisation of diverse institutional logics described in this study was used to try to facilitate the implementation of eHealth and telemedicine in primary care. This practical contribution could be used in other primary care organisation that plans to introduce eHealth solutions as part of their practices. This study may also have practical implications for other healthcare organisations since the presence of diverse institutional logics is not unique to primary care. Firstly, this study confirms earlier studies that argue that co-existence of diverse logics is possible in everyday practice. However, we show that adjustmentalisation of the diverse logics rather than the balance of strengths between them, facilitates the transformation, regulation and coordination of the new eHealth practice in relation to established practices. Secondly, this study shows that the adjustmentalisation derives from societal challenges such as an ageing population, accessibility problems and the COVID pandemic that are used to legitimise the adjustmentalisation of diverse logics. Digital technology influences and interacts with all established logics, potentially acting as a separate, evolving logic. Coexistence and adaptation: Different logics coexist and transform through adjustmentalisation rather than competing or dominating each other.Digital technology's influence: Digital technology influences and interacts with all established logics, potentially acting as a separate, evolving logic.Changing healthcare conditions: New conditions and digital solutions in healthcare may shift the balance of logics, potentially normalising managerial and market logics.Patient empowerment and data ownership: Increasing emphasis on patient empowerment and transparent data processing under regulations like GDPR and MDR.Future research directions: Need for further research on digital technology's impact on shift and balance between logics, business development, patient participation and its potential to become a dominant logic.

Advancing Health Equity in the Cardiovascular Device Life Cycle.

Despite advancements in diagnostics and therapeutics for cardiovascular disease, significant health disparities persist among patients from historically marginalized racial and ethnic groups, women, individuals who are socioeconomically under-resourced or underinsured, and those living in rural communities. While transcatheter interventions have revolutionized the treatment landscape in cardiology, populations bearing the greatest burden of disease continue to face inequitable access and poorer outcomes. A notable gap in the literature concerns the role of modern approaches to cardiovascular device innovation in shaping and perpetuating health disparities. Health equity has been declared one of the top strategic initiatives for 2022 to 2025 by the Food and Drug Administration Center for Devices and Radiological Health, underscoring the need for greater attention, dialogue, and targeted interventions in this space. This narrative review uses the cardiovascular device life cycle as a conceptual framework to enhance understanding and guide future efforts to mitigate disparities in the field of interventional cardiology. Drawing on illustrative examples from interventional cardiology, we examine current practices in cardiovascular device regulation and approval, clinical trial evaluation, adoption patterns, and postprocedural outcomes with the aim of uncovering potential mechanisms of disparities and identifying opportunities for targeted interventions.

Advancement of post-market surveillance of medical devices leveraging artificial intelligence: ECG devices case study

Background After 25 years of implementing the Medical Devices Directive (MDD), in 2017, the new Medical Devices Regulation (MDR) came into force, establishing stricter requirements for post-market surveillance of the safety and performance of medical devices (MD). For electrocardiogram (ECG) devices, which are crucial for monitoring cardiac activities, these requirements are essential to ensure the reliability and accuracy of diagnosing cardiac conditions and timely treatment. Objective This study aims to enhance post-market surveillance of ECG devices by leveraging Machine Learning (ML) algorithms to predict the operational status of these devices. Specifically, the research focuses on classifying the success or failure of ECG device operations based on performance and safety parameters. The ultimate goal is to improve the management strategies of ECG devices in healthcare institutions, ensuring optimal functionality and increasing the reliability of diagnostic procedures. Method During the inspection process of ECG devices conducted by an accredited laboratory in accordance with ISO 17020 standard in numerous healthcare institutions in Bosnia and Herzegovina, a total of 5577 samples were collected. Various machine learning algorithms, including Decision Tree (DT), Logistic Regression (LR), Random Forest (RF), Gaussian Naive Bayes (NB), and Support Vector Machine (SVM), were employed for result comparison and selection of the most accurate algorithm. Results All algorithms demonstrated good performance, but the Random Forest (RF) algorithm stood out, achieving 100% accuracy in predicting the success/unsuccess status of the device. While the results of this research are specific to the collected data from EKG devices, the developed algorithms can be applied to other similar datasets, offering opportunities for broader use in the medical environment. Conclusion Implementing machine learning algorithms for automated systems in healthcare institutions can significantly enhance the quality of patient diagnosis and treatment. Additionally, these systems can optimize costs associated with managing medical devices. Improved post-market surveillance using ML can address challenges related to ensuring device reliability and safety.

Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.

Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This article explores the historical evolution of medical device regulation, the role of standards organizations, and the impact of regulatory practices on device safety. Highlighting the critical need for stringent regulations, informed by instances where medical devices caused patient harm, we discuss the processes and collaborations between various international standards and regulatory frameworks that ensure device safety and effectiveness. This comprehensive review addresses the complexities of regulatory compliance and standardization, aiming to bridge the knowledge gap among healthcare providers and enhance the implementation of safety standards in medical technology.

Artificial Intelligence-Empowered Radiology—Current Status and Critical Review

Humanity stands at a pivotal moment of technological revolution, with artificial intelligence (AI) reshaping fields traditionally reliant on human cognitive abilities. This transition, driven by advancements in artificial neural networks, has transformed data processing and evaluation, creating opportunities for addressing complex and time-consuming tasks with AI solutions. Convolutional networks (CNNs) and the adoption of GPU technology have already revolutionized image recognition by enhancing computational efficiency and accuracy. In radiology, AI applications are particularly valuable for tasks involving pattern detection and classification; for example, AI tools have enhanced diagnostic accuracy and efficiency in detecting abnormalities across imaging modalities through automated feature extraction. Our analysis reveals that neuroimaging and chest imaging, as well as CT and MRI modalities, are the primary focus areas for AI products, reflecting their high clinical demand and complexity. AI tools are also used to target high-prevalence diseases, such as lung cancer, stroke, and breast cancer, underscoring AI’s alignment with impactful diagnostic needs. The regulatory landscape is a critical factor in AI product development, with the majority of products certified under the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Class IIa or Class I categories, indicating compliance with moderate-risk standards. A rapid increase in AI product development from 2017 to 2020, peaking in 2020 and followed by recent stabilization and saturation, was identified. In this work, the authors review the advancements in AI-based imaging applications, underscoring AI’s transformative potential for enhanced diagnostic support and focusing on the critical role of CNNs, regulatory challenges, and potential threats to human labor in the field of diagnostic imaging.

Efficacy of brief behavioral and sleep hygiene education with mindfulness intervention on sleep, social jetlag and mental health in adolescence: a pilot study.

Sleep is often compromised in adolescents, affecting their health and quality of life. This pilot-study was conducted to evaluate if implementing brief-behavioral and sleep-hygiene education with mindfulness intervention may positively affect sleep-health in adolescents. Participants in this community-based non-randomized cohort-study volunteered for intervention (IG)- or control-group (CG). Sleep was recorded during regular school-schedule for 3-school-nights and 2-non-school-nights with an FDA-cleared/EU-Medical Device Regulation(CE-2862) compliant home sleep test, and Questionnaires were utilized to evaluate chronotype, sleepiness, insomnia-, anxiety- and depression-symptoms. The four-week intervention included sleep-hygiene education, mindfulness- and breathing-practices for one-hour, twice weekly. Data was collected during the last-week of February and first two-weeks of March 2023 and repeated after intervention. Fifty-five participants completed the study, IG (86%) and CG (77%). Average age was 17.3-years and prevalence of severe social-jetlag (SJL) 72%. Participants who quit participation (n = 10) after baseline data-collection all females (3-IG/7-CG) in comparison to participants who completed the study were sleepierthan the IG and CG (+ 2.6-p = 0.04; + 3.8-p = 0.001), with more symptoms of insomnia- (+ 3.8-p = 0.002; + 4.7-p < 0.0001), and depression (+ 16.7-p < 0.0001; + 19.6-p < 0.0001), and report being later-chronotypes, (-18.2, p < 0.0001;-13.1, p < 0.0001). On average the IG advanced sleep-onset (32-min; p = 0.030), decreased SJL (37-min; p = 0.011) and increased total sleep time (TST, 29-min; p = 0.088)compared to the CG. Average sleep duration did not differ significantly comparing IG and CG after intervention. Stratifying participants with severe SJL (> 2-h) at baseline; 1) responders (61%) advanced sleep-onset on non-school-nights (96-min) and decreased SJL (103-min; p < 0.001) 2) non-responders (39%) increased sleep-duration on school-nights (36-min) and non-school-nights (63-min) but maintained severe-SJL. Teacher-lead sleep-education and mindfulness program can improve TST and SJL in adolescence.

Self-absorption effects of internal luminescence in one-dimensional nanowires with and without localized states

Recent rigorous demonstration of self-absorption (SA) effects of internal luminescence in solids [H. G. Ye et al. Sci. Bull. 62, 1525 (2017)] has opened a breach in the solid wall behind which the SA processes and effects occur but cannot be directly probed inside the solid. Herein, we attempt to present a further theoretical consideration of the SA effects of internal luminescence occurring inside a nanowire with Urbach band-tail states. The consideration begins with an ideal luminescence spectrum with δ-line shape and then goes to the cases of luminescence spectra with Lorentzian, Gaussian, and localized-state ensemble (LSE) line shapes, respectively. A quantitative consideration of the SA effects in the spectral features of external luminescence spectra along with the nanowire axis is established for the variables of temperature, transmission distance, and photon energy. Generally, it is found that the self-absorption of internal luminescence can have a significant impact on the spectral features of external luminescence, depending on the three above-mentioned variables. In particular, the influence of SA on the three key spectral parameters, including intensity, peak position, and full width at half maximum (FWHM) of external LSE luminescence, is unveiled, providing a quantitative explanation for a few experimental phenomena reported in the literature. In addition, some interesting phenomena, i.e., nearly no peak shift with increasing the transmission distance, etc., have been predicted. These results more deeply establish the theoretical foundation of self-absorption, which is of positive significance for the regulation and enhancement of optoelectronic devices.

Tongue Prick Bionic Angularly Adjustable Microneedles for Enhanced Scarless Wound Healing

AbstractHigh‐tension site wounds are frequently accompanied by challenges associated with hypertrophic scarring. The key to achieving scar‐free healing is the creation of a mechanical environment conducive to scar‐free skin regeneration. Herein, simple rolling punctures are utilized on angle transform molds to develop cat tongue prick bionic angle‐adjustable microneedles (TPMNs) to maintain a firm grip on the periwound skin, thereby reducing tissue tension. The integration of TPMNs with triboelectric nanogenerators (TENGs) enables excellent conductive and triboelectric properties. The system can provide a stable spatial electric field around the wound to promote cell migration. As the microfluid reaches the TPMNs, the self‐driving force is enhanced by a unique angle design to control the microfluid flow rate. Sufficient evidence has shown that TPMNs expedite wound contraction and skin tissue regeneration while concurrently reducing scar formation in mouse trauma model experiments. The innovative TPMNs‐TENGs synergistically provides a highly functional platform for wound tension relief, which is suitable for scar treatment in this study and potentially extends to the construction and regulation of smart wearable devices.

Business Venturing in Regulated Markets-Taxonomy and Archetypes of Digital Health Business Models in the European Union: Mixed Methods Descriptive and Exploratory Study.

Digital health technology (DHT) has the potential to revolutionize the health care industry by reducing costs and improving the quality of care in a sector that faces significant challenges. However, the health care industry is complex, involving numerous stakeholders, and subject to extensive regulation. Within the European Union, medical device regulations impose stringent requirements on various ventures. Concurrently, new reimbursement pathways are also being developed for DHTs. In this dynamic context, establishing a sustainable and innovative business model around DHTs is fundamental for their successful commercialization. However, there is a notable lack of structured understanding regarding the overarching business models within the digital health sector. This study aims to address this gap and identify key elements and configurations of business models for DHTs in the European Union, thereby establishing a structured understanding of the archetypal business models in use. The study was conducted in 2 phases. First, a business model taxonomy for DHTs was developed based on a systematic literature review, the analysis of 169 European real-world business models, and qualitative evaluation through 13 expert interviews. Subsequently, a 2-step clustering analysis was conducted on the 169 DHT business models to identify distinct business model archetypes. The developed taxonomy of DHT business models revealed 11 central dimensions organized into 4 meta-dimensions. Each dimension comprises 2 to 9 characteristics capturing relevant aspects of DHT business models. In addition, 6 archetypes of DHT business models were identified: administration and communication supporter (A1), insurer-to-consumer digital therapeutics and care (A2), diagnostic and treatment enabler (A3), professional monitoring platforms (A4), clinical research and solution accelerators (A5), and direct-to-consumer wellness and lifestyle (A6). The findings highlight the critical elements constituting business models in the DHT domain, emphasizing the substantial impact of medical device regulations and revenue models, which often involve reimbursement from stakeholders such as health insurers. Three drivers contributing to DHT business model innovation were identified: direct targeting of patients and private individuals, use of artificial intelligence as an enabler, and development of DHT-specific reimbursement pathways. The study also uncovered surprising business model patterns, including shifts between regulated medical devices and unregulated research applications, as well as wellness and lifestyle solutions. This research enriches the understanding of business models in digital health, offering valuable insights for researchers and digital health entrepreneurs.

3D Printing Facility in Healthcare Institutions: An Effective Strategy to be Compliant with Medical Device Regulation EU 2017/745

3D Printing Facility in Healthcare Institutions: An Effective Strategy to be Compliant with Medical Device Regulation EU 2017/745

Mechanisms of interlayer friction in low-dimensional homogeneous thin-wall shell structures and its strain effect.

Due to the multi-factor coupling effect, the rule of interlayer friction in low-dimensional homogeneous thin-wall shell structures is still unclear. Double walled carbon nanotubes (DWCNTs) having a typical low-dimensional homogeneous thin-wall shell structure are selected for this study. The interlayer friction of numerous chiral DWCNTs is investigated using molecular dynamics simulations to systematically analyze and understand the coupling mechanisms of various factors in interlayer friction. To eliminate the influence of the edge effect, a high-speed pure rotation model is used. The results demonstrate that DWCNTs with varying mismatch angle, interlayer distance, and interfacial radius exhibit distinct interlayer frictions and strain effects, due to the differences in interlayer interaction, atomic vibrational amplitudes, and lattice periods. Theoretical analysis is conducted on the interlayer friction and its strain effect based on the theoretical model. Based on phonon spectrum analysis, the vibrational modes and energy dissipation of DWCNTs with different chiral combinations under various strains are demonstrated. Based on the analysis, physical insight into the variation in friction forces is provided. The findings of this work deepen the understanding of the interlayer friction and strain mechanism and provide a theoretical basis for further exploitation of the strain effect to realize the regulation of nanoelectromechanical devices.

Impact of the European Medical Device Regulation on the availability of medical devices: Scoping review and two-year analysis on the risk for patients in the cardiovascular field

The implementation of the Medical Devices Regulation (MDR) 2017/745/EU leaves manufacturers facing new requirements to certify their medical devices (MDs). Our objective is to accurately assess the impact of regulation on the availability of cardiovascular MDs in healthcare facilities. High-risk cardiovascular MDs appear to be heavily impacted by the regulation, with reclassification leading to mandatory clinical investigations. Access to new MDs could be restricted by the increase in clinical evidence that must be provided. However, our analysis has shown that some manufacturers are focusing on innovative cardiovascular MDs, at the expense of marketing existing product lines. The unavailability of MDs has impacted the practice of physicians in patient care. Healthcare professionals are requesting exceptional exemptions from national authorities to use the MDs. To combat these shortages, amendments to the MDR have been introduced, such as the extension of the MDs recertification deadline and the introduction of a reporting system to anticipate shortages. European and national institutions are becoming aware of the supply difficulties associated with the regulation. A tool for sharing information and proposing alternatives would simplify the management of these shortages.

Evolutionary game analysis on the regulation of medical devices used in health services delivery

Medical devices (MDs) play a critical role in healthcare delivery while also bringing potential medical risks and unintended harms to patients. Although government regulation is well recognized as a critical and essential function for ensuring the safety of MDs in many countries, the supplementary role that hospitals play is often neglected. This paper constructs a tripartite evolutionary game model involving the government, hospitals, and MDs enterprises to explore their strategic behaviors of MDs regulation in healthcare delivery. We performed theoretical analysis and numerical simulations to examine the stability of stakeholders’ strategy selections. Our results reveal that: (1) Evolutionarily stable strategy (ESS) can be reached under specific revenue conditions for the government, hospitals, and MDs enterprises. (2) Penalty intensities largely affect the convergence rates of hospital strict management and enterprise quality improvement strategies. (3) Whistleblowing is an efficient factor to influence strategy selections of the hospital and MDs enterprise. Based on these findings, we propose policy recommendations to enhance MDs regulation effectiveness, including encouraging hospitals’ engagement in regulation, promoting whistleblowing with more public participation, balancing penalty systems, and strengthening multi-party cooperation.

Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review.

The integration of connected medical devices (MDs) into health care brings benefits but also introduces new, often challenging-to-assess risks related to cybersecurity, which have the potential to harm patients. Current regulations in the European Union and the United States mandate the consideration of these risks in the benefit-risk analysis (BRA) required for MD approval. This important step in the approval process weighs all the defined benefits of a device with its anticipated risks to ensure that the product provides a positive argument for use. However, there is limited guidance on how cybersecurity risks should be systematically evaluated and incorporated into the BRA. This scoping review aimed to identify current legal frameworks, guidelines, and standards in the United States, Canada, South Korea, Singapore, Australia, the United Kingdom, and the European Union on how cybersecurity risks should be considered in the BRA of MDs. This scoping review followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) framework. A systematic literature search of 10 databases was conducted in two phases on July 3, 2024 and September 30, 2024, including the guidance databases of the Food and Drug Administration, the Medical Device Coordination Group, and other International Medical Device Regulators Forum members; the International Medical Device Regulators Forum database; PubMed; and Scopus. Search terms included "cybersecurity," "security," "benefit/risk," "benefit-risk," and "risk-benefit." Additional references were identified via citation searching and expert interviews. Inclusion criteria were met if a document was a guideline or standard in force that provided guidance on the BRA or cybersecurity risks of MDs. Documents were excluded when they were not relevant to MDs, they were limited to a subclass of devices, they were about in vitro diagnostic MDs or investigational devices, and the content of the source was insufficient to undertake a scientific analysis. Data were extracted and analyzed using MAXQDA 2022, and the findings were narratively summarized and visualized in figures and tables. The search identified 150 documents, with 34 (22.7%) meeting the inclusion criteria. These 34 documents included 4 (12%) regulations, 5 (15%) standards, 6 (18%) technical reports, and 19 (56%) guidance documents. While cybersecurity risks were acknowledged in most documents, detailed methods for their integration into the BRA were lacking. Some standards and guidelines provided examples of how to consider cybersecurity risks in the BRA, but a comprehensive and standardized approach was lacking. This review highlights a substantial gap between the recognition of cybersecurity risks in MDs and the guidance on their incorporation into the BRA. Standardized frameworks are needed to provide clear methods for evaluating cybersecurity risks and their impact on the safety and security of MDs.

Best practices for disinfection in dental settings: insights from Italian and European regulations.

Disinfection practices in dental settings are fundamental to clinical safety, playing a pivotal role in preventing cross-infections and protecting the health of patients and healthcare professionals. This article examines the key components of effective disinfection, based on evidence-based protocols developed by international organizations such as the WHO and the U.S. CDC, alongside European and Italian regulatory standards. Dental instruments require stringent sterilization by autoclave or chemical methods, while high-level disinfection is essential for non-sterilizable items. Clinical surfaces require routine biocidal treatment tailored to microbial hazards and material compatibility. The European Biocidal Products Regulation and the Medical Devices Regulation provide critical oversight, ensuring product safety and effectiveness while preventing resistance. Antiseptics also play a vital role in oral care, with applications ranging from infection prevention to the treatment of periodontal disease, and are governed by strict regulatory frameworks. Disinfection effectiveness is significantly affected by factors such as microbial load, presence of biofilm, pH, temperature and biocide exposure time. Preventing bacterial resistance requires appropriate germicide selection, adherence to manufacturer protocols, robust sterilization and cleaning procedures. In addition, the increased use of disinfection during public health emergencies highlights the need for adaptability to mitigate evolving risks. Regular audits, biological tests, and training for healthcare personnel ensure the consistent application of these rigorous protocols. By integrating international and national standards, dental facilities achieve a uniform approach to hygiene and safety, advancing public trust and compliance. This article highlights the imperative for ongoing research and dissemination of best practices to enhance infection control in dental care environments.

Coordinating Research and evidence for Medical Devices (CORE MD) and beyond

Medical device regulations have its focal center on translating expert knowledge into advice for EU regulatory guidance, and building expertise in regulatory science in the clinical community, the Coordinating Research and Evidence for Medical Devices (CORE MD) project is here to review methodologies for the clinical evaluation of high-risk medical devices and recommend new designs to set an appropriate balance between innovation, safety, and clinical effectiveness. CORE-MD is a European Union Horizon 2020 project which began in April 2021 and was concluded in March 2024. For the first time ever CORE–MD consortium stands to bring together 33 medical associations, on one platform. The major objective of CORE MD is, developing guidance for evaluation of artificial intelligence. CORE MD includes cardiovascular, and diabetes medical devices, since these exemplify devices are used to reduce mortality and morbidity, the use of real-world evidence in regulatory decision making, evidences from clinical trials on High-risk medical devices, establishment of post approval evidence development schemes, tools to retrieve public information on medical devices and information on the performance of these High-Risk Medical Devices. As a result, the need for more sources to provide clinical evidences for medical devices is required, before they are approved for implantation in patients and to add on the focus, CORE MD project has brought brilliant potential in increasing the use of benefit measures and accelerating surrogate outcomes research which would optimize an implant’s benefit-risk ratio and making CORE-MD an ambitious project with great scope.

Quality Audits in Medical Device manufacturing: Best Practices and Challenges

Quality management system audits are an essential component of maintaining regulatory compliance, ensuring product safety, and continuously improving the performance of medical devices. As the medical device industry grows rapidly complex due to global regulations, technological advancements, and patient safety requirements, these management system audits play a critical role in ensuring that manufacturers meet standards such as ISO 13485: 2016, and CDSCO regulations, FDA regulations (21 CFR 820), and EU Medical Device Regulation (MDR). This article explores best practices for conducting quality audits in medical device manufacturing, identifies common challenges, and offers solutions for overcoming the challenges. The paper also examines how effective audits contribute to enhancing product quality, ensuring regulatory compliance, and fostering a culture of continuous improvement in medical device companies based on the survey results from ISO CASCO Committee.

Development of a digital risk-prediction tool based on family health history for the general population: legal and ethical implications.

Cardiovascular diseases, both inherited and familial, indicate a risk of early and preventable cardiovascular events for relatives of affected individuals. A digital risk-prediction tool that enables general population individuals to evaluate their cardiovascular risk based on family health history could be a responsible approach to facilitate early detection and improve public health, but development and use of such a tool is not without legal and ethical requirements. At the start of tool development, experts addressed potential legal and ethical implications. Especially European Union (EU) regulations could present potential obstacles for the tool's development, broader availability and general use. A first example is that the EU General Data Protection Regulation does not allow the tool to collect health data about relatives without their consent; the alternative is data anonymisation. This requirement has major consequences for the tool's usefulness and raises ethical concerns about who 'the owner' is of family data. A second example is related to the EU's Medical Device Regulation: if software generates health risks or provides medical advice, it requires a CE mark from a 'notified body', an extensive and costly procedure. In this article, we describe these implications in more detail and discuss possible solutions. To conclude, alongside national law, European law can impact on the development of digital tools that collect family health data to provide information on health risks. We recommend including experts in law and ethics in developmental stages of such tools which are likely to become more frequent in routine public care.