scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

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.

Post Marketing Surveillance of in vitro Diagnostic System in the European Union

2020 ◽  
Vol 07 ◽  
Author(s):  
Himadri Singh
Keyword(s):  
European Union ◽  
Medical Device ◽  
Diagnostic System ◽  
The European Union ◽  
Post Marketing Surveillance ◽  
In Vitro Diagnostic ◽  
Clinical Benefits ◽  
Post Marketing ◽  
And Performance

: Advances in medical device technology and regulatory authorization adapt to changing requirements and market conditions. The assessment of safety and performance in real world scenario will help us in understanding of clinical benefits and help in evolution of the medical device and in vitro diagnostic devices. The paradigm shift in evaluation of medical devices and in vitro diagnostic devices will ensure that the device deliver intended benefits. This articles discusses the new approach of the post marketing surveillance in the context of new in vitro diagnostic regulation in the European Union.

scholarly journals Companion Diagnostics: State of the Art and New Regulations

2021 ◽  
Vol 16 ◽  
pp. 117727192110477
Author(s):  
Vasiliki Valla ◽  
Saba Alzabin ◽  
Angeliki Koukoura ◽  
Amy Lewis ◽  
Anne Ahlmann Nielsen ◽  
...  
Keyword(s):  
Medical Devices ◽  
Clinical Performance ◽  
The European Union ◽  
Companion Diagnostics ◽  
Scientific Validity ◽  
Wide Range ◽  
In Vitro Diagnostic ◽  
And Performance ◽  
Therapeutic Decision Making

Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.

Sign in / Sign up

Export Citation Format

Share Document