scholarly journals THE NORMATIVE REGULATION OF MEDICAL DEVICES – A GUARANTOR FOR THE PROTECTION OF PATIENTS’ RIGHTS AS USERS OF HEALTH SERVICES IN THE REPUBLIC OF BULGARIA

2019 ◽  
Vol 34 (5) ◽  
pp. 1567-1572
Author(s):  
Mikael Chakaldziyan
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Equipment ◽  
Individual Case ◽  
Medical Law ◽  
The European Union ◽  
Actual Object ◽  
European Legislation ◽  
Consumer Law ◽  
The Republic

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.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

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

scholarly journals Analysis of Service Maintenance of Medical Equipment in State Organizations of the Republic of Kazakhstan. Policy Brief

2021 ◽  
Vol 2 (42) ◽  
pp. 76-85
Author(s):  
Ainara Tuleubaeva ◽  
◽  
Assem Kabykenova ◽  
Keyword(s):  
Medical Devices ◽  
Medical Equipment ◽  
Professional Training ◽  
Medical Personnel ◽  
Policy Options ◽  
Healthcare Organizations ◽  
Medical Organization ◽  
Computerized Maintenance Management System ◽  
The Republic ◽  
State Organizations

What are the problems? • Overestimation of the cost of service work at the "officials"; • Underpricing by unscrupulous suppliers who do not have the necessary knowledge and skills to service medical devices; • Deficit of financial resources between the actual need and the planned expenditures of budgetary funds for the maintenance of medical devices; • Lack of MI engineers in healthcare organizations; Lack of medical equipment on the basis of a medical organization on an ongoing basis. Quite often, medical technicians work in parallel in several medical organizations, which in turn leads to downtime of broken equipment that could be repaired immediately; • Insufficiently developed practice of training medical personnel on the basis of equipment manufacturers or an institution providing professional training in servicing relevant types of equipment; Policy options • Option 1. Amendments to the Normative legal acts of the Republic of Kazakhstan. • Option 2. Competent center, centrally dealing with the issues of medical equipment breakdowns. • Option 3. Implementation of a computerized maintenance management system for medical equipment. Key provisions Each of these policy options can contribute to the development of service provision for medical technology in the Republic of Kazakhstan. At the same time, in combination, they can lead to more effective changes. Key words: medical equipment, medical equipment, service, service of medical devices, Kazakhstan.

scholarly journals PENERAPAN ALGORITMA APRIORI UNTUK PENGADAAN OBAT DAN ALAT KESEHATAN PADA DEPARTEMENT RADIOLOGI MAYAPADA HOSPITAL

2019 ◽  
Vol 16 (2) ◽  
pp. 99-104
Author(s):  
Muhammad Afif ◽  
Dewi Ayu Nur Wulandari
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
High Frequency ◽  
Medical Equipment ◽  
Radiology Department ◽  
Long Period ◽  
Demand Patterns

The pattern of drug and medical device needs at Mayapada Hospital in South Jakarta has a tendency to be repeated and similar in a relatively long period of time, especially in one particular department, because the cases found are often similar or even similar. Ensuring the availability of stock in each department's deposit is very vital, because the procurement of medical equipment must go through a certain process and time, so there are often cases where there is a critical resus but the equipment needed in the deposit does not meet the needs or escape from inventory and must indent first. By calculating the tendency (Apriori Association) demand patterns in the relevant departments, especially in the radiology department at Mayapada Hospital, South Jakarta, a rule was formed that resulted in a pattern of dependency between itemsets that had supporting criteria in the form of support of 33.3% and Confidence by 85%, where the items that appear are items with a high frequency of appearance and association, so they can be taken into consideration to ensure the availability of drugs and medical devices.

scholarly journals Marketing Analysis: Antiemetic Drugs on the Pharmaceutical Market of Uzbekistan

2021 ◽  
Author(s):  
Samedinova Dilnoza Nuriddin qizi ◽  
Yunusova Kholida Mannanovna
Keyword(s):  
Medical Practice ◽  
Medical Devices ◽  
Medical Equipment ◽  
Dosage Forms ◽  
Pharmaceutical Market ◽  
State Register ◽  
Antiemetic Drugs ◽  
Marketing Analysis ◽  
The Republic ◽  
Audit Program

Abstract In this study, we analysed, with the help of the “State Register of Medicines, Medical Devices and Medical Equipment Permitted for Use in Medical Practice of the Republic of Uzbekistan”, the number, dosage forms and cost of registered antiemetic drugs in 2016-2020 based on the DRUG AUDIT program, which offers a database of information from 2016 to 2020.

Regulation and Clinical Investigation of Medical Device in the European Union

2019 ◽  
Vol 6 (3) ◽  
pp. 163-181
Author(s):  
Manita ◽  
Aakash Deep ◽  
Vikram ◽  
Avtar C. Rana ◽  
Prabodh C. Sharma
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
Healthcare Sector ◽  
World Population ◽  
The European Union

Background:: Medical devices are the machine, tool, instrument, apparatus, implant, calibrator in vitro, software, the similar or related object intended for use by the manufacturer alone or in combination becoming increasingly important in the healthcare sector as these are used to diagnosis, control, prevention or treatment of an illness. Safety of the world population is the highest priority in order to launch new medical devices for the treatment and diagnostic of several diseases. New innovation in industries and regulations work together to provide devices for different world market and to improve quality and safety of exiting devices in the market. The main key for devices is to classify the determination of actual regulatory pathway which ensures the safety standards and other regulatory requirements in a specific country. We perform clinical trials for medical device which are quite different from the clinical trials performed for drug analysis. For any high-risk devices, the new EU law states that the manufacturer has to prepare a complete summary for their evidence. The clinical trials regulation provides more transparency on clinical trials data. Complete transparency is required for the maximum possibility of informed decisions in order to use new medical devices. Objective:: The current manuscript will provide the information regarding the regulatory framework for the approval of medical devices and clinical investigation of medical device in European Union and comparison of approval process of medical device in USA, EU and India. The aim of this paper is to provide an overview of the most suitable and emerging requirements that manufacturers need for introducing their medical devices in the market in compliance with the MDR regulations. Conclusion:: The proposal for a modified regulation of medical devices aims to ensure more robust clinical data in support of the CE marking applications of the medical device. The clinical investigation requirements will be mandatory, and there will be an obligation to demonstrate the clinical benefits of the device and provide a rigorous equivalence test if the assessment is based on comparison devices. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

scholarly journals In-depth review on ‘innovation and regulatory challenges of the drug delivering medical devices’

2018 ◽  
Vol 15 (1) ◽  
pp. 18-28
Author(s):  
Patel Drashti ◽  
Charmy S Kothari ◽  
Singh Shantanu ◽  
Shah Manan
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
High Growth ◽  
Growth Potential ◽  
Guidance Document ◽  
The European Union ◽  
Profit Margins ◽  
The Us ◽  
High Growth Potential ◽  
Regulatory Challenges

The medical device market is generally seen as an area with high growth potential and provides greater profit margins including significant positive benefits to the patients. As the medical device regulations and the guidance document are becoming stringent in the US, manufacturers of these types of products are now facing these conundrums along with a need for clarification on matters related to various drug and device provisions. The European Union is making major changes to the Medical Device Directive which is its regulatory scheme for devices. Some parts are focused on the medical devices. The new changes in the regulations represent an important step forward in the growing philosophy of medical devices in Europe. Along with the regulatory challenges, there are various challenges faced during the innovation of such products. There are many factors that affect innovation including the patent aspects. In general, the key thing is that small firm face lots of difficulty compared to larger firm in bringing medical device in market. Thus, the proposed manuscript focuses on understanding the regulatory issues in various countries for ease of innovation and marketing authorization of medical devices.

scholarly journals Changes to the International Regulatory Environment

2012 ◽  
Vol 6 (2) ◽  
Author(s):  
Martin McHugh ◽  
Fergal McCaffery ◽  
Valentine Casey
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
The United States ◽  
Development Project ◽  
Regulatory Approval ◽  
Data Systems ◽  
The European Union ◽  
Class Iii ◽  
Rule Changes ◽  
Final Rule

Since 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD) 2007/47/EC and the United States (US) Food and Drug Administration (FDA) final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III-high risk to Class I-low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of an amendment to the directive have a direct impact on the development of medical devices. One of the most significant changes as part of this amendment is for software to be potentially considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas, such as the use of mobile device applications for healthcare purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of.

When Does Stand-Alone Software Qualify as a Medical Device in the European Union?—The Cjeu’s Decision in Snitem and What it Implies for the Next Generation of Medical Devices

2020 ◽  
Vol 28 (3) ◽  
pp. 615-624
Author(s):  
Timo Minssen ◽  
Marc Mimler ◽  
Vivian Mak
Keyword(s):  
European Union ◽  
Medical Device ◽  
Medical Devices ◽  
Paradigm Shift ◽  
Regulatory Framework ◽  
The European Union ◽  
Medical Purpose ◽  
Court Of Justice ◽  
Definition Of ◽  
Support Software

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

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Author(s):  
A G Fraser ◽  
R G H H Nelissen ◽  
P Kjærsgaard-Andersen ◽  
P Szymański ◽  
T Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

Abstract 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, whereas authorizing the placing on the market of medical devices is decentralized to independent ‘conformity assessment’ organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, 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.

scholarly journals Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices)

2021 ◽  
Vol 6 (10) ◽  
pp. 839-849
Author(s):  
Alan G. Fraser ◽  
Rob G.H.H. Nelissen ◽  
Per Kjærsgaard-Andersen ◽  
Piotr Szymański ◽  
Tom Melvin ◽  
...  
Keyword(s):  
High Risk ◽  
Medical Device ◽  
Medical Devices ◽  
Real World ◽  
Clinical Investigation ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
European Federation ◽  
The European Union ◽  
Clinical Investigations

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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