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Regulatory developments in the medical devices sector: A long and difficult journey 医疗器械行业的监管发展:漫长而艰难的旅程
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.1
Catherine Simonin
{"title":"Regulatory developments in the medical devices sector: A long and difficult journey","authors":"Catherine Simonin","doi":"10.54920/scto.2023.rawatch.8.1","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.1","url":null,"abstract":"Because the development of medical devices, device users, and the devices themselves often cross borders, medical device regulations in Switzerland are closely aligned with those of the European Union. Therefore, the Regulatory Affairs Watch editorial team wanted to hear first-hand from a European stakeholder who has been involved in this matter since the events that triggered the changes to European medical device regulation. In this first Deep Dive article, Catherine Simonin, MD, who is actively engaged in France’s Ligue contre le cancer (LCC, league against cancer) and the overarching national patient organisation France Assos Santé, discusses some of the drivers of regulatory changes for medical devices. The LCC has long been advocating for medical device legislation to focus more on patient safety, and the effects of its advocacy efforts can be seen in the EU’s changing legislative landscape. Using a Q&A format, Catherine Simonin also presents the perspective of patients and patient organisations on the EU’s recent Medical Device Regulation.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"63 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131170828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patient input into medical device development: A missed opportunity 患者对医疗设备开发的投入:一个错失的机会
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.5
Steven Bourke
{"title":"Patient input into medical device development: A missed opportunity","authors":"Steven Bourke","doi":"10.54920/scto.2023.rawatch.8.5","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.5","url":null,"abstract":"The delivery of care to people who are patients has, beyond doubt, reached the digital age. This is never more striking than in the area of medical devices and in vitro diagnostic medical devices. Patients’ standard of care has risen exponentially in light of the technological and innovative advances in the medical device field. Yet, in many instances, medical device development is undertaken without patient input. This article discusses why it is important to include patients’ perspective in the process of developing medical devices. In addition, it addresses several related topics, such as the issue of access to medical devices and the need for transparency with regards to the data collected by medical devices. It also provides an example of a research project aimed to better understand and promote patient engagement in medical device development.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123088662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Swissmedic’s experience with the regulatory changes for clinical investigations with medical devices implemented in 2021 Swissmedic在2021年实施的医疗器械临床研究监管变化方面的经验
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.3
I. Scuntaro, Simone Frank, Y. Nägelin
{"title":"Swissmedic’s experience with the regulatory changes for clinical investigations with medical devices implemented in 2021","authors":"I. Scuntaro, Simone Frank, Y. Nägelin","doi":"10.54920/scto.2023.rawatch.8.3","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.3","url":null,"abstract":"Swissmedic, the Swiss Agency for Therapeutic Products, evaluates and approves clinical trials of medical devices in humans if the devices are not CE-marked or are used off-label. These activities are conducted by the Medical Devices Clinical Investigations division, which also ensures continuous surveillance while the clinical trials are in progress. In 2021, the European Medical Device Regulation introduced new requirements for clinical investigations with medical devices. In parallel, the new Swiss Ordinance on Clinical Trials with Medical Devices came into force, applying the European requirements in Switzerland. This legislation introduced major changes to medical device requirements and authorisation procedures. In this article, Swissmedic summarises its stakeholder-oriented response to these legislative changes. In addition, it refers to new information sheets, templates, and decisions trees that are available.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"30 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122637261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Changes to the medical device regulatory framework: Looking back – and forward 医疗器械监管框架的变化:回顾与展望
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.2
Pietro Gervasoni
{"title":"Changes to the medical device regulatory framework: Looking back – and forward","authors":"Pietro Gervasoni","doi":"10.54920/scto.2023.rawatch.8.2","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.2","url":null,"abstract":"The new regulatory framework for medical devices was long due. It aims to improve the safety and performance of medical devices and ensure a high level of protection for public health. Yet complying with the new legislation requires greater administrative effort and more resources, thus making compliance more expensive. In addition, there has been some uncertainty among researchers about how to correctly comply with the new legislation. This article looks back at the measures swissethics has taken to address some of these challenges and looks forward to additional measures to be implemented in the future.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132007171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The PES-SLEEP project: A practical approach to the categorisation challenge for studies with medical devices PES-SLEEP项目:对医疗器械研究的分类挑战的实用方法
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.6
Hélène Maby-El Hajjami, S. Diessler, P. Franken, M. Froissart
{"title":"The PES-SLEEP project: A practical approach to the categorisation challenge for studies with medical devices","authors":"Hélène Maby-El Hajjami, S. Diessler, P. Franken, M. Froissart","doi":"10.54920/scto.2023.rawatch.8.6","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.6","url":null,"abstract":"Since the revised Medical Devices Ordinance (MedDO) and the new Ordinance on Clinical Trials with Medical Devices (ClinO-MD) entered into force in Switzerland in May 2021, clinical investigators have encountered challenges in correctly categorising their research projects and identifying whether their projects pertain to the category of clinical studies with medical devices (governed by the ClinO-MD) or are considered human research other than clinical trials (governed by Chapter 2 of the Human Research Ordinance (HRO)). In this article, we discuss the PES-SLEEP project in order to illustrate a practical approach to this categorisation challenge between the lighter HRO regulatory framework and the more demanding ClinO-MD pathway. We also present the important points that were considered by the ethics committee for the canton of Vaud (EC Vaud) in order for the study to be approved as an HRO research project.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114618905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Challenges facing Switzerland’s medical technology industry following the 2021 changes to medical device legislation 2021年医疗器械立法变更后，瑞士医疗技术行业面临的挑战
Regulatory Affairs Watch Pub Date : 2023-06-01 DOI: 10.54920/scto.2023.rawatch.8.4
D. Delfosse
{"title":"Challenges facing Switzerland’s medical technology industry following the 2021 changes to medical device legislation","authors":"D. Delfosse","doi":"10.54920/scto.2023.rawatch.8.4","DOIUrl":"https://doi.org/10.54920/scto.2023.rawatch.8.4","url":null,"abstract":"In order to improve the safety of medical devices, the European Union and Switzerland made significant changes to their respective medical device legislation, which went into effect on 26 May 2021. The same day, Switzerland lost its privileged access to the European market. These legislative and political changes have impacted not only medical device manufacturers but also patients. This article discusses the challenges to the supply of medical devices in Switzerland and outlines what is needed to overcome them.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115403626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Model-based meta-analysis in drug and device development and the added value of data sharing 药物和器械开发中基于模型的元分析及数据共享的附加价值
Regulatory Affairs Watch Pub Date : 2022-06-01 DOI: 10.54920/scto.2022.rawatch.7.28
T. Muka
{"title":"Model-based meta-analysis in drug and device development and the added value of data sharing","authors":"T. Muka","doi":"10.54920/scto.2022.rawatch.7.28","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.28","url":null,"abstract":"Meta-analysis, the highest level of evidence, is a statistical analysis that includes a mathematical combination of the results from different studies. Meta-analysis can be a subset of systematic review or the pooling of results from individual patient data (IPD). The number of published systematic reviews and meta-analyses has grown exponentially in recent years: a search in PubMed showed that around 1,600 systematic review and meta-analysis publications were indexed in 2000 compared to over 35,000 in 2020. And this upward trend is projected to continue. With the new regulatory landscape making the development and maintenance of clinical evaluation reports (CERs) a priority for drug and device manufacturers, methodologically sound meta-analysis will be key to guiding strategic drug and device development decisions.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134019290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Data protection in clinical trials: Key issues from a legal perspective 临床试验数据保护:法律视角下的关键问题
Regulatory Affairs Watch Pub Date : 2022-06-01 DOI: 10.54920/scto.2022.rawatch.7.18
Philipp do Canto
{"title":"Data protection in clinical trials: Key issues from a legal perspective","authors":"Philipp do Canto","doi":"10.54920/scto.2022.rawatch.7.18","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.18","url":null,"abstract":"Human research is one of the most regulated academic domains. A main focus of regulations is the protection of trial participants’ physical integrity and personal data. In Switzerland, the federal Human Research Act (HRA) and its related ordinances are primarily relevant. These research regulations contain provisions on how research data are to be managed in order to protect participants’ data privacy. When cantonal universities conduct clinical trials, they must also comply with their cantonal data protection laws. Standards set by the EU and international organisations also have a major impact on human research. Despite the increased protection of personal data, there is some room for improvement. This article reviews the legal basis for data privacy in Switzerland as it relates to research participants’ data and takes a closer look at a few key issues from the perspective of study participants.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133666493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Meta-research: Using shared data to provide practical solutions for current research challenges 元研究:利用共享数据为当前的研究挑战提供切实可行的解决方案
Regulatory Affairs Watch Pub Date : 2022-06-01 DOI: 10.54920/scto.2022.rawatch.7.32
M. Briel, A. Gayet-Ageron, S. Trelle
{"title":"Meta-research: Using shared data to provide practical solutions for current research challenges","authors":"M. Briel, A. Gayet-Ageron, S. Trelle","doi":"10.54920/scto.2022.rawatch.7.32","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.32","url":null,"abstract":"Research on research (RoR), or meta-research, is the study of research itself. In 2019, a group of meta-researchers and members of the SCTO’s Clinical Trial Unit Network interested in meta-research founded the Swiss clinical Trials Empirical Assessment & Methods (STEAM) working group to promote RoR in Switzerland. Specifically, STEAM aims to continually improve the quality, transparency, and value of Swiss clinical research through RoR. The first part of this article takes a brief look at why RoR is needed and describes its potential role in the Swiss clinical research arena. The second part of the article discusses the topic of data sharing in clinical research from a meta-research perspective.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"70 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131536756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
How the CoLaus | PsyCoLaus study shares data while ensuring privacy CoLaus | PsyCoLaus研究如何在确保隐私的同时共享数据
Regulatory Affairs Watch Pub Date : 2022-06-01 DOI: 10.54920/scto.2022.rawatch.7.35
P. Marques-Vidal
{"title":"How the CoLaus | PsyCoLaus study shares data while ensuring privacy","authors":"P. Marques-Vidal","doi":"10.54920/scto.2022.rawatch.7.35","DOIUrl":"https://doi.org/10.54920/scto.2022.rawatch.7.35","url":null,"abstract":"While data sharing is important in an international research setting, ensuring the privacy of participants is just as important. For several years, the CoLaus | PsyCoLaus study has been sharing data with national and international research teams while ensuring that no breach of privacy regarding the participants occurs. A series of procedures have been put in place, including checking the research protocol, data encryption, and legally binding agreements. The original data are also distributed between sites and informatics systems, thus making re-identification of the participants difficult. These procedures allow a high level of security, and the participants are guaranteed that no data leakage will occur.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"81 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132845897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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