scholarly journals Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations

2021 ◽  
Vol 34 (3) ◽  
pp. 201
Author(s):  
Carla Pires ◽  
Dinah Duarte ◽  
Afonso Cavaco
Keyword(s):  
European Union ◽  
Medical Device ◽  
Medical Devices ◽  
Text Message ◽  
Open Market ◽  
The European Union ◽  
Counterfeit Products ◽  
National Competent Authorities ◽  
European Union Member States ◽  
Regulatory Actions

Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

A Regulatory and Safety Perspective on Medical Devices

2021 ◽  
pp. 1815-1826
Author(s):  
Carla Pires ◽  
Dinah Duarte
Keyword(s):  
European Union ◽  
Adverse Events ◽  
Member State ◽  
Medical Devices ◽  
Future Development ◽  
The European Union ◽  
Serious Adverse Events ◽  
International Laws ◽  
Counterfeit Products

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.

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.

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.

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.

The effect of Brexit on, and changes in, the European Union medical device regulations

2021 ◽  
pp. 1-5
Author(s):  
Mike Pogose ◽  
Karandeep Badwal ◽  
Xiao Liu ◽  
Hugh Harvey
Keyword(s):  
European Union ◽  
Medical Device ◽  
Medical Devices ◽  
Clinical Settings ◽  
The European Union ◽  
The Uk ◽  
Substantial Change ◽  
Regulatory Landscape

With the exit of the UK from the European Union and the European Union Regulation 201/745 coming into effect on 26 May 2021, the regulatory landscape for medical devices is undergoing a substantial change, the implications of which will be felt by those procuring and using medical devices in clinical settings. This article outlines the changes that clinicians, as users of medical devices, should be aware of in the immediate future.

scholarly journals What asylum and refugee policies do Europeans want? Evidence from a cross-national conjoint experiment

2021 ◽  
pp. 146511652110068
Author(s):  
Anne-Marie Jeannet ◽  
Tobias Heidland ◽  
Martin Ruhs
Keyword(s):  
European Union ◽  
The European Union ◽  
Public Preferences ◽  
Refugee Protection ◽  
Political Debates ◽  
Conjoint Experiment ◽  
Refugee Policies ◽  
European Union Member States ◽  
Asylum Seekers And Refugees ◽  
Cross National

The protection of asylum seekers and refugees has become one of the most politically divisive issues in the European Union, yet there has been a lack of research on public preferences for asylum and refugee policies. This article analyzes which policies Europeans prefer and why. We advance a theoretical framework that explains how asylum and refugee policies that use limits and conditions enable individuals to resolve conflicting humanitarian and perceived national interest logics. Using an original conjoint experiment in eight countries, we demonstrate that Europeans prefer policies that provide refugee protection but also impose control through limits or conditions. In contrast to the divisive political debates between European Union member states, we find consistent public preferences across European countries.

scholarly journals Castaño avoids a clash between the ECtHR and the CJEU, but erodes Soering. Thinking human rights transnationally

2020 ◽  
pp. 203228442097974
Author(s):  
Sibel Top ◽  
Paul De Hert
Keyword(s):  
European Union ◽  
Human Rights ◽  
Union Member ◽  
The European Union ◽  
Member States ◽  
Court Of Justice ◽  
European Court ◽  
Criminal Matters ◽  
European Union Member States

This article examines the changing balance established by the European Court of Human Rights (ECtHR) between human rights filters to extradition and the obligation to cooperate and how this shift of rationale brought the Court closer to the position of the Court of Justice of the European Union (CJEU) in that respect. The article argues that the ECtHR initially adopted a position whereby it prioritised human rights concerns over extraditions, but that it later nuanced that approach by establishing, in some cases, an obligation to cooperate to ensure proper respect of human rights. This refinement of its position brought the ECtHR closer to the approach adopted by the CJEU that traditionally put the obligation to cooperate above human rights concerns. In recent years, however, the CJEU also backtracked to some extent from its uncompromising attitude on the obligation to cooperate, which enabled a convergence of the rationales of the two Courts. Although this alignment of the Courts was necessary to mitigate the conflicting obligations of European Union Member States towards both Courts, this article warns against the danger of making too many human rights concessions to cooperation in criminal matters.

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