Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.1
Catherine Simonin
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.
由于医疗设备的开发、设备用户和设备本身经常跨越国界，瑞士的医疗设备法规与欧盟的法规密切一致。因此，监管事务观察编辑团队希望听到欧洲利益相关者的第一手资料，他自引发欧洲医疗器械监管变化的事件以来一直参与此事。在这篇深度报道的第一篇文章中，Catherine Simonin医学博士，积极参与法国抗癌联盟(LCC, league against cancer)和主要的国家患者组织France Assos sant，讨论了医疗器械监管变化的一些驱动因素。LCC长期以来一直倡导医疗器械立法更多地关注患者安全，其倡导努力的效果可以在欧盟不断变化的立法格局中看到。使用问答格式，Catherine Simonin还提出了患者和患者组织对欧盟最近的医疗器械法规的看法。
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Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.5
Steven Bourke
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.
{"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}
Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.3
I. Scuntaro, Simone Frank, Y. Nägelin
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.
瑞士医疗产品管理局(Swiss Agency for Therapeutic Products)负责评估和批准医疗器械在人体中的临床试验，如果这些器械没有ce标志或在标签外使用。这些活动由医疗器械临床调查司进行，该司还确保在临床试验进行期间进行持续监测。2021年，欧洲医疗器械法规引入了医疗器械临床调查的新要求。与此同时，新的瑞士医疗器械临床试验条例生效，在瑞士适用欧洲的要求。该立法对医疗器械的要求和授权程序进行了重大修改。在本文中，Swissmedic总结了其以利益相关者为导向的对这些立法变化的回应。此外，它还涉及可用的新信息表、模板和决策树。
{"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}
Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.2
Pietro Gervasoni
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.
{"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}
Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.6
Hélène Maby-El Hajjami, S. Diessler, P. Franken, M. Froissart
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.
{"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}
Pub Date : 2023-06-01DOI: 10.54920/scto.2023.rawatch.8.4
D. Delfosse
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.
{"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}
Pub Date : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.28
T. Muka
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.
{"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}
Pub Date : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.18
Philipp do Canto
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.
{"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}
Pub Date : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.32
M. Briel, A. Gayet-Ageron, S. Trelle
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.
{"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}
Pub Date : 2022-06-01DOI: 10.54920/scto.2022.rawatch.7.35
P. Marques-Vidal
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.
{"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}
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