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Journal articles on the topic 'Regulation of medicines and medical devices'

Author: Grafiati
Published: 12 December 2022
Last updated: 26 January 2023

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1

Parvizi, Nassim, and Kent Woods. "Regulation of medicines and medical devices: contrasts and similarities." Clinical Medicine 14, no. 1 (February 2014): 6–12. http://dx.doi.org/10.7861/clinmedicine.14-1-6.

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2

Мурашко, Михаил, and Mihail Murashko. "2019: time for innovations (following the conference «FarmMed Appeal–2019»)." Vestnik Roszdravnadzora 2019, no. 3 (June 26, 2019): 5–20. http://dx.doi.org/10.35576/article_5d135f4a303e79.40852064.

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The article presents major directions of the modern regulation over circulation of medicines and medical devices including biomedical cellular products. Particular attention is focused on matters of the purchase of medicines and medical devices, the drug label and the maintenance of a safety of medical products.
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3

Ordeanu, Viorel, Lucia Ionescu, Victoria Dumitrescu, Roxana Pricop, Razvan Neagu, and Diana Popescu. "Medical devices in current medicine." Romanian Journal of Military Medicine 123, no. 4 (November 1, 2020): 253–57. http://dx.doi.org/10.55453/rjmm.2020.123.4.3.

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The treatment of diseases is based on pharmacological and non-pharmacological means, but adequate devices are needed for their application. Medicine uses a wide range of medical devices. Currently, many medical devices are used, many of them being disposable. As recognition of the importance of medical devices, the national authority of the drug is the ANMDM (National Agency for Medicines and Medical Devices). Medical devices are indispensable for therapy, and their evolution has led to an extraordinary diversification of the field and the emergence of industry related to the pharmaceutical industry, with specific laws and regulations.
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4

Chejor, Pelden, Jigme Tenzin, and Jigme Dorji. "Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities." International Journal of Drug Regulatory Affairs 6, no. 2 (June 15, 2018): 54–58. http://dx.doi.org/10.22270/ijdra.v6i2.243.

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Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one country to another. Medical products including vaccines, blood and blood products, diagnostics and medical devices are essential for healthcare delivery across the world. The Drug Regulatory Authority (DRA) is an independent national agency for regulation of medicinal products in Bhutan and reports to Bhutan Medicines Board (BMB), the highest policy making body for regulation of medicinal products in the country. Medicines Act of the Kingdom of Bhutan is the legal tool for regulation of medicines in Bhutan. Medicinal products are regulated through premarketing and post-marketing control systems. All medicinal products available in the Bhutanese market are registered. DRA regulates all the medicinal products including vaccines, blood products and traditional medicines used for human and veterinary. DRA is fully financed by the Government of Bhutan. Bhutan’s medicines regulatory system has evolved over the last one decade. However, as the regulatory mandate continues to increase, DRA is faced with several challenges in terms of human resource, infrastructure and testing laboratory among others. There are also opportunities for the DRA to improve its regulatory capacities to ensure availability of quality and safe medicines for the public. Understanding the current practice of medicines regulation in Bhutan can help identify gaps and existing opportunities for improving the regulatory capacity. This article documents the existing practices, challenges and opportunities for regulation of medicinal products in Bhutan.
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Altenstetter, Christa. "EU AND MEMBER STATE MEDICAL DEVICES REGULATION." International Journal of Technology Assessment in Health Care 19, no. 1 (January 2003): 228–48. http://dx.doi.org/10.1017/s0266462303000217.

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This article examines European Union (EU) and member state regulation of medical devices, particularly: a) the similarities and differences between medical devices and prescription drugs, including the respective industries, market authorization pathways, and boundary issues between the two sectors; b) the political background, current nature, and future prospects for EU medical device regulation; and c) regulatory responsibilities of the member states. Included are definitions of medical devices and in vitro diagnostics, and a brief history of their treatment by European law. The erosion of boundaries between exclusive and shared responsibilities of the EU and member states will be addressed, especially as it affects market approval of medical devices, clinical investigations, labeling and instructions for use, price setting and reimbursement, and evidence-based medicine and healthcare technology assessment. Finally, the article discusses medical device reporting and surveillance systems, which may be the weakest link in the EU integrative process. If patient safety is as important to the EU regulatory scheme as free movement and competitiveness, then both Brussels and member states will require additional resources, as well as measures to overcome obstacles to implementation, evaluation, and accountability.
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6

Lesmana, Giannina Meracellene, Matthew Darrell Tenando, and Vienda Mustika Dewi. "Pharmaceutical and Medical Devices Industry Regulation in Indonesia: Human Rights Perspective." Jurist-Diction 5, no. 2 (March 31, 2022): 521–36. http://dx.doi.org/10.20473/jd.v5i2.34892.

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AbstractA deficiency in supply of medicines and medical devices, especially in remote areas, has become a national problem since the mid-2000s until now. This problem is certainly made worse by the presence of COVID-19. The main causes of this supply shortages are, among others, economic factors, ineffective regulations that result in problems related to business and supply chains. Indonesia, a country where 90% of raw materials for medicines are imported from abroad, of course is deeply affected by the export ban of countries that supply raw materials. Do not forget that Indonesia's geographical condition is so vast that it creates huge obstacles for the distribution of drugs and medical devices, and it is understandable if the private sector does not want to open hospitals, pharmacies or clinics in remote areas due to economic factors. As a result, human health, something which should be a human right feels like a luxury during this pandemic. Therefore several policies have been implemented, ranging from increasing production capacity, enacting regulations regarding limits on the number of drugs that can be prescribed to patients or purchased by the public to prevent hoarding, simplifying the industrial licensing process to increasing hospital beds.Keywords: Medical Devices; Medicine; COVID-19. AbstrakKurangnya pasokan obat dan alat kesehatan khususnya di daerah terpencil telah menjadi masalah nasional sejak pertengahan tahun 2000-an hingga saat ini. Masalah ini tentunya diperburuk oleh adanya COVID-19. Penyebab utama kekurangan pasokan ini diantara lain karena faktor ekonomi, regulasi yang kurang efektif yang mengakibatkan masalah terkait bisnis dan juga rantai pasok. Indonesia sebuah negara dimana 90% bahan baku obat obatan didatangkan dari luar negeri tentu sangat terpengaruh oleh larangan ekspor negara negara pemasok bahan baku. Tidak lupa kondisi geografis Indonesia yang begitu luas menghasilkan kendala yang begitu besar untuk distribusi obat dan alat medis, dan dapat dipahami jika pihak swasta tidak ingin membuka rumah sakit, apotek ataupun klinik di daerah terpencil karena faktor ekonomis. Lantas kesehatan yang seharusnya adalah Hak Asasi Manusia terasa seperti kemewahan di pandemi ini. Oleh sebab itu beberapa kebijakan yang dilakukan yaitu mulai dari meningkatkan kapasitas produksi, memberlakukan peraturan mengenai batasan jumlah obat yang dapat diresepkan untuk pasien atau dibeli oleh masyarakat untuk mencegah penimbunan, simplifikasi proses perizinan industri hingga memperbanyak tempat tidur rumah sakit.Kata Kunci: Alat kesehatan; Farmasi; COVID-19.
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7

Green, James IJ. "The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices." British Journal of Hospital Medicine 81, no. 12 (December 2, 2020): 1–6. http://dx.doi.org/10.12968/hmed.2020.0596.

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The 1990s saw the implementation of three European directives that aimed to standardise medical device legislation. EU regulations replace and repeal these directives, to improve the safety, effectiveness and traceability of medical devices. This article discusses the implications of the Regulation (EU) 2017/745 (Medical Device Regulation) for hospital doctors who prescribe and manufacture custom-made medical devices.
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8

Antich Isern, Pau, and Juan Aparicio Blanco. "The borderline with medical devices in the current Spanish legal framework." Anales de la Real Academia Nacional de Farmacia 88, no. 88(02) (June 30, 2022): 209–34. http://dx.doi.org/10.53519/analesranf.2022.88.02.06.

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Medical devices cover a wide range of products essential for healthcare. In 2017 a new European regulation covering them was approved that fully applies from 2021 onwards. In it, their legal definition, classification, conformity assessment procedures, requirements for the clinical investigations that asses their safety and/or performance, and European database are specified. Despite the efforts for systematizing the legal definition of medical device in the new regulation, the determination of the legal status of devices known as ‘borderline products’, for which different regulations may apply (like in the borderline with food supplements, cosmetics, personal care products, biocides, personal protective equipment and consumer products), is not without difficulties. On account of their therapeutic significance, this review delves into the borderline between medicinal products and medical devices, and differentiates them from presentations where medicinal products and medical devices are used in combination, without constituting a borderline. Establishing updated definitions, promoting transparency in the sector and preventing conflicts of interest should motivate all stakeholders to the periodic review of the regulation in a field in continuous technological evolution and development.
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9

Філінюк, О. М., Д. В. Алешко, М. М. Бабенко, К. Л. Косяченко, and Р. Кахвечі. "Decision-making regulatory framework of the introduction of health technologies at the hospitals in Ukraine." Farmatsevtychnyi zhurnal, no. 1 (February 23, 2022): 6–14. http://dx.doi.org/10.32352/0367-3057.1.22.01.

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The limited resources of the health care system and the COVID-19 pandemic encourage more rational and cost-effective administrative and clinical decisions. To achieve the best health care within available resources, the introduction of the most efficient technologies should be supported, considering organizational, social and ethical issues. Assessment of health technologies at different levels, namely national/regional and hospital, is becoming increasingly important. Adherence to cost-effective approaches to administrative and clinical decision-making will ensure the rational use of the state budget and improve clinical outcomes, improve the quality and life expectancy of patients. The purpose of the study was to analyze the current regulatory framework for the introduction of health technologies (medicines and medical devices) at the hospital level. During the research the methods of content analysis, historical, system-analytical, generalization was used. According to the analysis of the decision-making regulatory framework for the health technology’s introduction, it was drawn the next conclusions. The active HTA development in Ukraine is noted. In a short time, a legal framework for state HTA for medicines was created and approved, amendments were made to the Law of Ukraine ‘On Public Procurement’ and other Ukraine’s laws on medicine procurement under managed entry agreements, the further steps for development of the HTA ecosystem in Ukraine were identified. The legal framework for the circulation of medical devices needs to be updated in Ukraine, starting with technical regulations in accordance with EU regulations №745 and №746 and further approval of the Law on Medical Devices. Procedures for evaluation and selection of medicines and medical devices at the level of medical institutions are absent in Ukraine and require separate elaboration. The introduction of HB-HTA will help hospital managers to make independent, transparent, reasonable, and impartial management decisions on the selection of drugs and medical devices. The obtained results prove the need for further research of everyday decision-making practices on the introduction of health technologies at the hospitals, development of methodology for hospital-based HTA and update regulation of HB-HTA in the current legal framework of Ukraine.
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10

Chakaldziyan, Mikael. "THE NORMATIVE REGULATION OF MEDICAL DEVICES – A GUARANTOR FOR THE PROTECTION OF PATIENTS’ RIGHTS AS USERS OF HEALTH SERVICES IN THE REPUBLIC OF BULGARIA." Knowledge International Journal 34, no. 5 (October 4, 2019): 1567–72. http://dx.doi.org/10.35120/kij34051567c.

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Health is envisaged as a right of the citizens both in the Constitution of the Republic of Bulgaria and in the Treaty on the Functioning of the European Union. Healthcare is subject to regulation by a number of secondary European legislation acts as well as by acts of our domestic legislation. The overall state policy on health care provision and development constitutes a complex set of diverse activities. Its quality is largely the result of strict and good-faith implementation of the normative regulations, addressing both public authorities and individuals. Exercising preventive medical procedures, adequate diagnosis and conducting successful treatment are undoubtedly essential parts of healthcare. This essential part is implemented by healthcare professionals with specific qualifications and by using medicinal products that contribute to achieving positive results in each patient's health in every individual case. In turn, medical equipment such as apparatus, instruments, materials and other supplies, plays an increasingly important and crucial role in the overall process of the actual implementation of medical assistance. Today, secondary European legislation determines medical equipment as a medical device and defines it. The continued development of science in the field of medicine, as well as in other fields, is an important factor in achieving ever greater opportunities for medical care and determines the significant place of medical devices in the provision of healthcare to a particular patient. Using them is often the only way to correctly diagnose a patient, though the cases where the medicinal product itself comes into contact with the patient's body through a medical device are also not isolated. The presence of the appropriate type of medical device and its corresponding level of quality are essential prerequisites for proper diagnosis and conducting a precise treatment procedure to achieve the optimal end effect. To ensure a positive result in the patient's health, medical devices must be safe and meet a number of quality requirements. The safety and quality of medical devices are a prerequisite for the actual realization of the right to healthcare for citizens. This report examines some administrative-juridical remedies for exercising control over medical devices, as well as certain obligations that individuals should carry out when performing activities related to medical devices. Bearing in mind the actual object of protection in medical law - the patient, and that one of the principles of consumer law is to protect the life and health of the consumer as an individual, it is concluded that medical and consumer law have the same object of protection and that is every individual. The report makes a comparative analysis of the administrative-juridical measures taken by the Medicines Executive Agency and by the Consumer Protection Commission. It also compares some of the obligations that private law entities need to observe in medical law in respect to medical devices and those of private parties in consumer law regarding goods.
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11

Kwong, Man Ting, David Stell, and Emmanuel Akinluyi. "Medical Device Regulation from a Health Service Provider’s Perspective." Prosthesis 3, no. 3 (September 14, 2021): 261–66. http://dx.doi.org/10.3390/prosthesis3030025.

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Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation.
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12

Lee, Paul T., and John Terry. "Changing practice to using pre-filled syringes for flushing IV cannulas." British Journal of Nursing 30, no. 14 (July 22, 2021): S14—S22. http://dx.doi.org/10.12968/bjon.2021.30.14.s14.

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In the UK, the Medicines and Healthcare products Regulatory Agency classifies ‘pre-filled syringes’ for flushing Intravenous (IV) cannulas and IV access devices as ‘borderline’ devices and offers some advice on how control measures can help mitigate risks. The Medicines Act (1968) and Medical Device Regulations try to address the legal position of these devices and allow each employer to identify those groups of staff allowed to use them. In turn, this may help address anomalies around the need to prescribe and document their use. This article describes how one large university health board in Wales implemented a change in products and practice and explores the issues around adopting and using CE-marked pre-filled, sterile syringes of 0.9% sodium chloride in place of manually drawing up an IV flush (the CE mark indicates devices that conforms with European legal requirements). Whether the use of individual components or a single pre-filled device can lead to a streamlined and cost-effective way to manage the flushing of IV cannula and vascular access devices was explored. Additional risk factors were identified, and the legal status clarified in line with current guidelines and regulations. As 0.9% sodium chloride in ampoules and vials is classified as a prescription-only medicine, the administration needs control via formal prescription or a patient group direction. Adopting and using these pre-filled syringes as CE-marked medical devices requires careful consideration and sign-off from each employing authority, before implementing them for flushing IV cannulas and IV access devices.
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13

McHale, Jean V. "Health law, Brexit and medical devices: A question of legal regulation and patient safety." Medical Law International 18, no. 2-3 (June 2018): 195–215. http://dx.doi.org/10.1177/0968533218807255.

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Brexit is already posing many major challenges for those concerned with health and social care. This article explores one area, that of the regulation of medical devices which has been fundamentally underpinned by EU law and asks what Brexit means for future regulation in the United Kingdom. This article begins by outlining the importance of ensuring standards of quality and safety for medical devices and the consequences if things go wrong. The second section of the article outlines the current EU regulation of medical devices. It explores questions such as the role of the notified bodies, the problems of lack of central regulation and the role of vigilance processes. The third section explores the options for medical device regulation post Brexit in the light of the ongoing reform of the law in this area and the implementation of new EU Regulations. It considers the prospects for reciprocity and for alignment in the future. The article concludes by arguing that, while the new system for regulation of medical devices in the EU is not perfect, it nonetheless provides an important opportunity for restructuring device regulation and providing greater opportunities for facilitating safety. It is important to ensure that, as far as possible, we do not lose such an opportunity at domestic level post Brexit.
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14

Faunce, Thomas A., Kellie Johnston, and Hilary Bambrick. "The Trans-Tasman Therapeutic Products Authority: Potential AUSFTA Impacts on Safety and Cost-Effectiveness Regulation for Medicines and Medical Devices in New Zealand." Victoria University of Wellington Law Review 37, no. 3 (September 1, 2006): 365. http://dx.doi.org/10.26686/vuwlr.v37i3.5574.

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Australia and New Zealand have agreed in principle to the creation of a single agency for the regulation of pharmaceuticals and other therapeutic products in a trans-Tasman market. The Australia New Zealand Therapeutic Products Authority (ANZTPA) is being developed to replace both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). This article explores the possibility that the ANZTPA, by inheriting significant obligations imposed on the TGA under the Australia-United States Free Trade Agreement (AUSFTA), may significantly impact upon the regulation of medicines and medical devices (as well as blood products) in New Zealand. It explores the related legal obligations and their likely consequences for New Zealand: particularly quality, safety, efficacy and cost-effectiveness evaluation processes in this area, such as those of the New Zealand Pharmaceutical Management Agency (Pharmac).
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15

Hartmann, Markus, and Florence Hartmann-Vareilles. "Concepts for the Risk-Based Regulation of Clinical Research on Medicines and Medical Devices." Drug Information Journal 46, no. 5 (September 2012): 545–54. http://dx.doi.org/10.1177/0092861512453574.

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16

Fraser, Alan G., Rob G. H. H. Nelissen, Per Kjærsgaard-Andersen, Piotr Szymański, Tom Melvin, and Paul Piscoi. "Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)." EFORT Open Reviews 6, no. 10 (October 2021): 839–49. http://dx.doi.org/10.1302/2058-5241.6.210081.

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In the European Union (EU), the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity assessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the Medical Device Directive, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details – which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE–MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024. Here, we describe how it may contribute to the development of regulatory science in Europe. Cite this article: EFORT Open Rev 2021;6:839-849. DOI: 10.1302/2058-5241.6.210081
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Koldeweij, Charlotte, Jonathan Clarke, Joppe Nijman, Calandra Feather, Saskia N. de Wildt, and Nicholas Appelbaum. "CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis." Journal of Medical Internet Research 23, no. 12 (December 13, 2021): e31333. http://dx.doi.org/10.2196/31333.

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Background Pediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. Objective This study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers. Methods A scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency’s online registry of medical devices, and by surveying app developers. The barriers to CE accreditation were also explored through a survey of app developers. Results Of 632 screened apps, 74 were eligible, including 60 pediatric drug dosage calculators and 14 infusion rate calculators. One app was CE marked. Of the 20 (34%) respondents to the survey, 8 considered their apps not to be medical devices based on their intent of use or functionality. Three developers had not aimed to make their app available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC apps included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in app stores. Conclusions The compliance of PDCs with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these apps.
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18

Green, James I. J. "Medical Device Regulation: Requirements for Dental Professionals Who Prescribe and Manufacture Custom-Made Devices." Primary Dental Journal 10, no. 1 (March 2021): 64–88. http://dx.doi.org/10.1177/2050168420980980.

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A custom-made device (CMD) is a medical device intended for the sole use of a particular patient. In a dental setting, CMDs include prosthodontic devices, orthodontic appliances, bruxism splints, speech prostheses and devices for the treatment of obstructive sleep apnoea, trauma prevention and orthognathic surgery facilitation (arch bars and interocclusal wafers). Since 1993, the production and provision of CMDs have been subject to European Union (EU) Directive 93/42/EEC (Medical Device Directive, MDD) given effect in the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618), and its subsequent amendments. Regulation (EU) 2017/745 (Medical Device Regulation, EU MDR) replaces the MDD and the other EU Directive pertaining to Medical Devices, Council Directive 90/385/EEC (Active Implantable Medical Device Directive, AIMDD). The EU MDR was published on 5 April 2017, came into force on 25 May 2017 and, following a three-year transition period was due to be fully implemented and repeal the MDD on 26 May 2020, but was deferred until 26 May 2021 due to the coronavirus disease 2019 (COVID-19) pandemic. In the UK, in preparation for the country’s planned departure from the EU, the EU MDR, with necessary amendments, was transposed into UK law (Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, UK MDR). The UK left the Union on 31 January 2020 and entered a transition period that ended on 31 December 2020, meaning that, from 1 January 2021, dental professionals in Great Britain who prescribe and manufacture CMDs are mandated to do so in accordance with the new legislation while Northern Ireland remains in line with the EU legislation and implementation date. This paper sets out the requirements that relate to the production and provision of CMDs in a UK dental setting.
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Kessler, David A., Stuart M. Pape, and David N. Sundwall. "The Federal Regulation of Medical Devices." New England Journal of Medicine 317, no. 6 (August 6, 1987): 357–66. http://dx.doi.org/10.1056/nejm198708063170606.

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Green, James I. J. "Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers." Primary Dental Journal 11, no. 2 (June 2022): 22–31. http://dx.doi.org/10.1177/20501684221101472.

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Dental professionals who practice in the UK must follow the General Dental Council (GDC) Standards, one of which is to “find out about laws and regulations that affect your work and follow them”. Dental professionals manufacture custom-made devices (CMDs) and the legislation that governs these devices has changed. Medical devices manufactured within the European Union (EU) were previously subject to Council Directive 93/42/EEC (Medical Devices Directive [MDD]), which was given effect in UK law by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) was scheduled to replace the MDD on 26 May 2020, but this was postponed for one year due to the coronavirus (COVID-19) pandemic. In preparation for the UK’s departure from the EU, the EU MDR was largely transposed into The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791 [UK MDR 2019]), which amended the UK MDR 2002, and was expected to come into effect on 1 January 2021 but a further amendment, The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478 [UK MDR 2020]), removed these provisions. As of 1 January 2021, medical devices in Great Britain are subject to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while those in Northern Ireland must be manufactured in accordance with the EU MDR. This paper provides the answers to some key questions regarding the documentation that must be supplied with CMDs following these changes.
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Green, James I. J. "Medical Device Regulations and custom-made device documentation: Ten frequently asked questions and their answers." Primary Dental Journal 11, no. 2 (June 2022): 22–31. http://dx.doi.org/10.1177/20501684221101472.

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Dental professionals who practice in the UK must follow the General Dental Council (GDC) Standards, one of which is to “find out about laws and regulations that affect your work and follow them”. Dental professionals manufacture custom-made devices (CMDs) and the legislation that governs these devices has changed. Medical devices manufactured within the European Union (EU) were previously subject to Council Directive 93/42/EEC (Medical Devices Directive [MDD]), which was given effect in UK law by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]) was scheduled to replace the MDD on 26 May 2020, but this was postponed for one year due to the coronavirus (COVID-19) pandemic. In preparation for the UK’s departure from the EU, the EU MDR was largely transposed into The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791 [UK MDR 2019]), which amended the UK MDR 2002, and was expected to come into effect on 1 January 2021 but a further amendment, The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (Statutory Instrument 2020/1478 [UK MDR 2020]), removed these provisions. As of 1 January 2021, medical devices in Great Britain are subject to either the UK MDR 2002 (as amended) or the EU MDR (until 30 June 2023) while those in Northern Ireland must be manufactured in accordance with the EU MDR. This paper provides the answers to some key questions regarding the documentation that must be supplied with CMDs following these changes.
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22

Potockova, H., P. Kusnierik, and J. Dohnal. "Note on the regulation of veterinary medical devices in the EU: A review of the current situation and its impact on animal health and safety." Animal Welfare 29, no. 1 (January 1, 2020): 37–43. http://dx.doi.org/10.7120/09627286.29.1.037.

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Medical devices form a large heterogeneous group of products ranging from simple tools to medical testing and implants, the safety and efficacy of which are strictly regulated in all developed countries. Thanks to the health and cost benefits, medical devices have also found their way into veterinary medicine but, surprisingly, the regulation of these products is far less complex or, in some cases, missing altogether. Given the complexity and potential hazards of certain veterinary devices, the current state of affairs may lead to health and safety risks, both for animals and personnel involved. This review is the first to systematically map the current situation in the EU, revealing health and safety risks in practice for both animals and personnel involved and discussing them in a broader context. Only six out of the EU's 28 member states (Belgium, Croatia, Czech Republic, Germany, Hungary, and Slovakia) were found to have at least a degree of regulation of veterinary devices. As a result, a single product may be regulated as a veterinary medicinal product, a veterinary medical device or not be regulated at all, depending on the particular EU member state in question. As things stand, veterinary medicine makes use of all kinds of medical devices, including human products, regardless of their regulatory status and (pre-market) control. However, the use of such devices may influence the health and well-being of animals. Several measures are therefore suggested to attain the required levels of safety and efficacy surveillance for veterinary medical devices without creating excessive administration.
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Higson, Gordon, and Lee T. Myers. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Medical Physics 30, no. 11 (November 2003): 3047. http://dx.doi.org/10.1118/1.1619134.

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Schnell-Inderst, Petra, and Claudia Wild. "PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment." International Journal of Technology Assessment in Health Care 35, S1 (2019): 43. http://dx.doi.org/10.1017/s026646231900196x.

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IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.
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O'Dowd, W. J. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Physics in Medicine and Biology 47, no. 2 (January 4, 2002): 349. http://dx.doi.org/10.1088/0031-9155/47/2/701.

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Yusko, James G. "Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety." Health Physics 82, no. 5 (May 2002): 749. http://dx.doi.org/10.1097/00004032-200205000-00019.

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Hoda, Farazul, Rishabh Verma, Mawrah Arshad, Ali Nasir Siddiqui, Mohammad Ahmed Khan, Mohammad Akhtar, and Abul Kalam Najmi. "Materiovigilance: Concept, Structure and Emerging Perspective for Patient’s Safety in India." Drug Research 70, no. 09 (August 3, 2020): 429–36. http://dx.doi.org/10.1055/a-1195-1945.

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AbstractThere has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?
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IVAMA-BRUMMELL, Adriana M., Daniella PINGRET-KIPMAN, Priscila G. LOULY, and Rosiene R. ANDRADE. "Medicines regulation, pricing and reimbursement in Brazil." Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde 13, no. 1 (March 25, 2022): 769. http://dx.doi.org/10.30968/rbfhss.2022.131.0769.

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Brazil is an upper-middle-income country with a high human development index (HDI) of 0.765 (2019). The Unique Health System (SUS) is a universal, decentralised system, free at point-of-care, although 27% of Brazilians have voluntary supplementary health insurance. Medicines are provided free-of-charge through the SUS, though there are a few exceptions where co-payment is required. Around 87% of the country’s expenditure with medicines and medical devices corresponds to out-of-pocket, highlighting the importance of price regulation. Marketing authorisation and maximum price approval are mandatory market entry requirements for medicines. Pricing policies include maximum price approval, regulation of mark-ups, tax exemption, annual price adjustment and a mandatory discount for government procurement and enforcement mechanisms. The pricing of new drugs considers the patent status and added therapeutic benefit. It is a combination of health technology assessment and external or internal reference pricing, while drugs with active ingredients in the market follow internal reference pricing. The maximum price of generics must be up to 65% of the reference’s price. The maximum approved prices and public procurement prices are publicly available. Brazil has a value-based decision-making process for incorporating medicines and other technologies at the SUS. Current areas of work include horizon scanning, participation of patients in decision-making and re-assessment of technologies. As a decentralised system, medicines are procured by the Ministry of Health, states and municipalities, according to their level of responsibility. Pricing and reimbursement policies, including a consolidated generics policy, have been important in promoting transparency, predictability, and price stability, in turn contributing to cost-containment and access. Ongoing challenges include high rates of judicialisation, medicines with excessive prices not commensurate with their clinical benefits, no provision for pricing review, problems related to governance and politics. To address these challenges, the authors have three main recommendations. First: improving regulatory governance, second: incentivising the development and promoting access to medicines with stronger evidence, added clinical benefit and fair prices, and third: increasing awareness among stakeholders, avoiding judicialisation and minimising its impact; contributing to closing the gap between innovation and access to medicines.
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Zaczyk, Marcin. "Legal and Normative Requirements Related to Medical Devices for Individual Supply in Clinical Practice." Ortopedia Traumatologia Rehabilitacja 23, no. 5 (October 31, 2021): 381–87. http://dx.doi.org/10.5604/01.3001.0015.4360.

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This article has the form of a communication presenting recent legal changes in relation to medical devices. Until 26 May 2021, three medical directives were in force, namely Directive 98/79 / EC, Council Directive 93/42/ EEC and Council Directive 90/385 / EEC. They have been replaced by two regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The article presents the reasons for introducing the changes and the new obligations that these changes bring for manufacturers of medical devices, in particular, products manufactured individually on a special order as necessary for the implementation of personalized therapies in clinical practice. There are also forecasts for the industry and end users of medical devices manufactured to order and used individually at medical centers.
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Śpiewla, Krzysztof, and Leszek Świeca. "Research on the identification of messages contained in the implicatures of advertisements of over-the-counter products sold in pharmacies in Poland." Media Biznes Kultura, no. 2 (9) (2020): 163–75. http://dx.doi.org/10.4467/25442554.mbk.20.023.13187.

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Reports by institutions monitoring this market show that of over PLN 7 billion spent annually in Poland on advertising, almost half is spent on advertising OTC medicines, medical devices and dietary supplements (Instytut Monitorowania Mediów, 2019). Considering this, and taking into account legal regulations that significantly limit promotion at the point of sale (Art. 93 of the Pharmaceutical Law Act), advertising seems to be the most important tool for stimulating demand for over-the-counter products as well as one a basic source of of the residents of Poland on ailments, their treatment and prevention. The study examined 71 advertisements, including 47 ads for medicines, 10 for medical devices, 12 for dietary supplements and 1 ad for food for special medical purposes. Among the sample, 27% ads contained manipulation in the marketing message. The current tools of market control institutions enable the analysis of explicit claims but not implied messages in advertising. Our analysis shows that this is not enough to protect patients and other market participants from misleading or false advertising. It is absolutely necessary to enhance the control over the advertising of medicines, dietary supplements and medical devices by analysing the implications contained in the advertisements.
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Śpiewla, Krzysztof, and Leszek Świeca. "Research on the identification of messages contained in the implicatures of advertisements of over-the-counter products sold in pharmacies in Poland." Media Biznes Kultura, no. 2 (9) (2020): 163–75. http://dx.doi.org/10.4467/25442554.mbk.20.023.13187.

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Reports by institutions monitoring this market show that of over PLN 7 billion spent annually in Poland on advertising, almost half is spent on advertising OTC medicines, medical devices and dietary supplements (Instytut Monitorowania Mediów, 2019). Considering this, and taking into account legal regulations that significantly limit promotion at the point of sale (Art. 93 of the Pharmaceutical Law Act), advertising seems to be the most important tool for stimulating demand for over-the-counter products as well as one a basic source of of the residents of Poland on ailments, their treatment and prevention. The study examined 71 advertisements, including 47 ads for medicines, 10 for medical devices, 12 for dietary supplements and 1 ad for food for special medical purposes. Among the sample, 27% ads contained manipulation in the marketing message. The current tools of market control institutions enable the analysis of explicit claims but not implied messages in advertising. Our analysis shows that this is not enough to protect patients and other market participants from misleading or false advertising. It is absolutely necessary to enhance the control over the advertising of medicines, dietary supplements and medical devices by analysing the implications contained in the advertisements.
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32

Roehr, B. "FDA seeks to modify regulation of medical devices." BMJ 341, aug12 1 (August 12, 2010): c4415. http://dx.doi.org/10.1136/bmj.c4415.

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33

Chen, Yuan-Chuan, Hwei-Fang Cheng, and Ming-Kung Yeh. "Cell Therapy Regulation in Taiwan." Cell Transplantation 26, no. 3 (March 2017): 483–92. http://dx.doi.org/10.3727/096368916x693293.

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Cell therapy is not only a novel medical practice but also a medicinal product [cell therapy product (CTP)]. More and more CTPs are being approved for marketing globally because of the rapid development of bio-medicine in cell culture, preservation, and preparation. However, regulation is the most important criterion for the development of CTPs. Regulations must be flexible to expedite the process of marketing for new CTPs. Recently, the Taiwan Food and Drug Administration (TFDA) updated the related regulations such as regulation of development, current regulatory framework and process, and the application and evaluation processes. When the quality of CTPs has been improved significantly, their safety and efficacy are further ensured. The treatment protocol, a new design for adaptive licensing to current clinical practice, is a rapid process for patients with life-threatening diseases or serious conditions for which there are no suitable drugs, medical devices, or other therapeutic methods available. The hospital can submit the treatment protocol to apply for cell therapy as a medical practice, which may result in easier and faster cell therapy development, and personalized treatment for individual patients will evolve quickly.
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34

Davies, Craig A. "Keeping advertisers honest - an overview of the regulation of the advertising of medicines and medical devices in Australia." Australian Prescriber 27, no. 5 (October 1, 2004): 124–27. http://dx.doi.org/10.18773/austprescr.2004.100.

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35

Solovyev, Oleg G. "Technical-legal aspects of the normative consolidation of the signs of the objective side of the crime provided for in Article 238.1 of the Criminal Code of the Russian Federation." Vestnik Yaroslavskogo gosudarstvennogo universiteta im. P. G. Demidova. Seriya gumanitarnye nauki 16, no. 3 (September 24, 2022): 446. http://dx.doi.org/10.18255/1996-5648-2022-3-446-453.

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The article analyzes the peculiarities of the regulation of criminal liability for the circulation of falsified, substandard and unregistered medicines, medical devices and the turnover of falsified biologically active additives (Article 238.1 of the Criminal Code of the Russian Federation). First of all, the author highlights violations of the general rules of legislative technique, which provide for compliance with the requirements of saving regulatory material, the use of similar terms in the construction of homogeneous compositions of crimes, etc. The author notes that it is necessary to normalize the level of punishability of single-order elements of crimes enshrined in Articles 235.1 and 238.1 of the Criminal Code of the Russian Federation by simultaneously indicating the large size of the acts committed in these criminal law prohibitions. The article notes the need for additional criminological analysis of other possible illegal actions with falsified, substandard or unregistered medicines, medical products and biologically active additives, such as - purchase, storage, transportation. The author also offers various options for interpreting the signs of the objective side, such as production and marketing, examines the features and controversial aspects of the qualification of an unfinished crime, explores the issues of excluding criminal liability in the manufacture of medicines and medical devices in the process of conducting clinical trials and research, and carrying out export operations.
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Shakhnazarov, B. A. "Intellectual Property as a Legal Mechanism Accompanying the Fight against the Pandemic in the context of the Spread of Coronavirus Infection (COVID-19)." Lex Russica, no. 8 (August 25, 2020): 134–47. http://dx.doi.org/10.17803/1729-5920.2020.165.8.134-147.

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The paper examines the legal problems of protection and use of intellectual property in the context of fighting the pandemic. It is noted that the recommendations proposed by the World Health Organization to identify, diagnose and isolate, as well as to provide assistance to patients with suspected coronavirus infection in a pandemic can be effectively implemented only with proper legal regulation of the protection of intellectual property rights to the relevant results of intellectual activity, stimulating relevant developments while maintaining a balance between private and public interests. The paper examines the modernization of Russian legislation in the sphere of relations under consideration. Of vital importance are developments related to medicines and medical devices in preventing and overcoming the consequences of the spread of infectious diseases; flexibility of the legislator and the need to implement special-simplified, accelerated-legal regimes for the introduction of medicines and medical devices into trade. The author summarizes regulations at the interface of the legislation on circulation of medicines and intellectual property law in Russia and abroad (USA, Germany), as well as at the supranational level (EAEC). In modern conditions, the possible rapid spread of viral infections and pandemic threats it is essential to establish the legal basis for the balance between the public interest and the interests of patent holders in national legislations, based on a harmonizing international treaty provisions. The authors considers the restriction of patent rights in the extreme urgency with the obligatory non-exclusive and temporary nature of the use of objects of patent rights by a third party based on such restrictions and the mandatory payment of a just compensation to patent holders together with accelerated and simplified mechanisms for registration and introduction into the turnover of the relevant medicines, including vaccines, be a justified and necessary tool to combat the pandemic and the best means of overcoming its consequences.
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37

Richards, Bernadette, Susannah Sage Jacobson, Mianna Lotz, and Wendy Rogers. "The Regulation of Medical Device Representatives: A Question of Trust?" Law, Technology and Humans 4, no. 1 (May 24, 2022): 117–28. http://dx.doi.org/10.5204/lthj.2281.

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The introduction of new technologies in medical treatment has led to innovation in medical devices that are highly technical in their application and operation. The medical technology landscape is changeable and healthcare providers often turn to the medical device representatives (MDRs), employed by device manufacturers to help navigate the shifts and uncertainties. While the relationship between MDRs and healthcare providers can be a positive one focusing on appropriate use, selection and safety of devices, it is one that has evolved over time and is not independently regulated. In addition, patients, for the most part, are usually unaware of the involvement of MDRs in their healthcare. It is this knowledge gap with regard to the role of MDRs that is the focus of this paper. We argue that trust is at the heart of healthcare relationships and explore the nature of trust alongside the models of regulation of the medical device industry. We argue that MDRs may currently present a threat to both the interpersonal and the institutional trust of patients, and that regulation and policy responses are appropriate ways to address this risk. We consider potential regulatory frameworks and identify transparency and communication as the crucial characteristics of an appropriate response. We recommend that the polycentric nature of Australian healthcare regulation be cultivated through a multilayered approach, and that a positive obligation to inform the patient of the role of MDRs in their clinical care be established.
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Lübbeke, Anne, James A. Smith, Daniel Prieto-Alhambra, and Andrew J. Carr. "The case for an academic discipline of medical device science." EFORT Open Reviews 6, no. 3 (March 2021): 160–63. http://dx.doi.org/10.1302/2058-5241.6.200094.

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Medical devices are a very important but largely under-recognized and fragmented component of healthcare. The limited regulation of the past and the lack of systematic rigorous evaluation of devices leading to numerous high-profile failures will now be replaced by stricter legal requirements and more transparent evaluation processes. This constitutes an unprecedented opportunity, but it also uncovers urgent needs in landscaping, methodology development, and independent comprehensive assessment of device risks and benefits for individual patients and society, especially in the context of increasingly complex devices. We argue that an academic discipline of ‘medical device science’ is well placed to lead and coordinate the efforts necessary to achieve much needed improvement in the medical device sector. Orthopaedics and traumatology could contribute and benefit considerably as one of the medical specialties with the highest use of medical devices. Cite this article: EFORT Open Rev 2021;6:160-163. DOI: 10.1302/2058-5241.6.200094
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Darrow, Jonathan J., Jerry Avorn, and Aaron S. Kesselheim. "FDA Regulation and Approval of Medical Devices: 1976-2020." JAMA 326, no. 5 (August 3, 2021): 420. http://dx.doi.org/10.1001/jama.2021.11171.

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Wise, J. "Medical devices regulation needs to be overhauled, says cardiologist." BMJ 343, oct14 2 (October 14, 2011): d6671. http://dx.doi.org/10.1136/bmj.d6671.

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Yamaguchi, Umio, and Hirokazu Chuman. "Overview of medical device regulation in Japan as it relates to orthopedic devices." Journal of Orthopaedic Science 18, no. 5 (September 2013): 866–68. http://dx.doi.org/10.1007/s00776-013-0418-x.

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Martelli, Nicolas, Déborah Eskenazy, Carole Déan, Judith Pineau, Patrice Prognon, Gilles Chatellier, Marc Sapoval, and Olivier Pellerin. "New European Regulation for Medical Devices: What Is Changing?" CardioVascular and Interventional Radiology 42, no. 9 (May 23, 2019): 1272–78. http://dx.doi.org/10.1007/s00270-019-02247-0.

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Horachuk, V., A. Krut, and V. Michaltchuk. "APPROACHES TO REGULATION OF MEDICAL PRODUCTS AS A CONDITION OF PREVENTION OF RISKS THEIR USE." Likarska sprava, no. 1-2 (March 25, 2018): 166–70. http://dx.doi.org/10.31640/jvd.1-2.2018(28).

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We studied domestic technical regulations for medical products, harmonized with European approaches to regulate their treatment. The materials of the study were documents on technical regulation, standardization, metrology, accreditation, conformity assessment procedures and market surveillance of the European Union and Ukraine (24 units). Methods of system approach and system analysis, descriptive modeling are used. It is established that the regulatory legal regulation of the circulation of medical devices in Ukraine does not contain the full scope of requirements with guarantees of their safety when used by health care institutions and could serve as the criteria for compliance with the performance of control functions by state market surveillance authorities. A list of technical documents formed in a technical file is proposed. Its purpose is to document the circulation of medical devices (manufacture, conduct clinical trials, use in public health institutions, market surveillance). Thus, there are opportunities to confirm the safety of medical devices, which is a component of ensuring the quality of medical care.
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Timsina, Sangita, Bhuvan K.C., Dristi Adhikari, Alian A. Alrasheedy, Mohamed Izham Mohamed Ibrahim, and Atisammodavardhana Kaundinnyayana. "A new experimental community pharmacy internship module for undergraduate pharmacy students in western Nepal: overview and reflections." Journal of Educational Evaluation for Health Professions 14 (August 16, 2017): 18. http://dx.doi.org/10.3352/jeehp.2017.14.18.

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Community pharmacies in Nepal and other South Asian countries are in a mediocre state due to poor regulation and the fact that many pharmacies are run by people with insufficient training in dispensing. This has led to the inappropriate use of medicines. The problems due to poor regulation and the mediocre state of community pharmacies in South Asia encompass both academia and clinical practice. In this paper, a 2-week community pharmacy internship programme completed by 2 graduating pharmacy students of Pokhara University (a Nepalese public university) at Sankalpa Pharmacy, Pokhara, Nepal is illustrated. During the internship, they were systematically trained on store management, pharmaceutical care, counselling skills, the use of medical devices, pharmaceutical business plans, medicine information sources, and adverse drug reaction reporting. An orientation, observations and hands-on training, case presentation, discussion, and feedback from 2 senior pharmacists were used as the training method. A proper community pharmacy internship format, good pharmacy practice standards, and a better work environment for pharmacists may improve the quality of community pharmacies.
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Tandy, Marlene K. "Industry perspective on FDA regulation of medical devices and the practice of medicine." Annals of Thoracic Surgery 61, no. 1 (January 1996): 485–86. http://dx.doi.org/10.1016/0003-4975(95)00989-2.

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Jarow, Jonathan P., Charles Viviano, and John H. Baxley. "How much clinical evidence is enough: regulation of medical devices?" Annals of Translational Medicine 4, no. 20 (October 2016): 414. http://dx.doi.org/10.21037/atm.2016.08.44.

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Kaufman, M. "AAMI/FDA International Conference on Medical Devices Standards and Regulation." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 75, no. 6 (June 1, 2005): 366–70. http://dx.doi.org/10.4286/ikakikaigaku.75.6_366.

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Campbell, B. "Regulation and safe adoption of new medical devices and procedures." British Medical Bulletin 107, no. 1 (July 29, 2013): 5–18. http://dx.doi.org/10.1093/bmb/ldt022.

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Green, Michael. "Tort Claims and Federal Regulation of Medical Devices vs Pharmaceuticals." JAMA 302, no. 11 (September 16, 2009): 1169. http://dx.doi.org/10.1001/jama.2009.1333.

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Maxwell, Katelynn. "Easing Medical Device Regulatory Oversight: The FDA and Testing Amidst the COVID-19 Pandemic." American Journal of Law & Medicine 47, no. 2-3 (July 2021): 291–326. http://dx.doi.org/10.1017/amj.2021.18.

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The FDA already subjects most medical devices to much less stringent approval requirements than drugs and biologics, and attempts to speed up rollout during the COVID crisis have been problematic. Agency decisions, including to allow antibody test marketing without emergency use authorization or review, and the back-and-forth guidance on laboratory-developed tests, have met harsh criticism and unreliable results. Though the long-term results of these decisions are unclear, the FDA’s credibility, reliability, and commitment to safety are threatened by even further lessening medical device regulatory oversight during the coronavirus pandemic. The relaxed and fix-it-later approach to many of the FDA’s public health emergency decisions regarding medical devices reflect the ongoing criticisms of medical device regulation in general, specifically the 510(k) process and laboratory developed test regulation, offering a point of reflection towards reform. Adaptive legislation and a risk-based and evidentiary approach to premarket and postmarket review can begin to address these issues both generally and in an emergency context.
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