Pub Date : 2019-10-01DOI: 10.54920/scto.2019.rawatch.2.16
How will the regulatory changes taking place for medical devices affect patients – those who carry the true risks or benefits of having them in or on their bodies? For a down-to-earth patient perspective, European Patients’ Academy (EUPATI) fellow Estelle Jobson met with Karen Topaz Druckman, President of the Swiss patient association, HHT Swiss, to ask her some questions. Karen’s views represent years in patient advocacy including patient input.
{"title":"Patient-to-patient: Talking about medical devices","authors":"","doi":"10.54920/scto.2019.rawatch.2.16","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.16","url":null,"abstract":"How will the regulatory changes taking place for medical devices affect patients – those who carry the true risks or benefits of having them in or on their bodies? For a down-to-earth patient perspective, European Patients’ Academy (EUPATI) fellow Estelle Jobson met with Karen Topaz Druckman, President of the Swiss patient association, HHT Swiss, to ask her some questions. Karen’s views represent years in patient advocacy including patient input.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128166378","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 : 2019-10-01DOI: 10.54920/scto.2019.rawatch.2.18
Claudia Becherer
{"title":"What about software used in human research?","authors":"Claudia Becherer","doi":"10.54920/scto.2019.rawatch.2.18","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.18","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131653981","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 : 2019-10-01DOI: 10.54920/scto.2019.rawatch.2.3
Mariagrazia Di Marco, Laure Vallotton
The regulatory landscape of medical devices is currently undergoing tremendous changes in the EU – changes that will directly affect Switzerland. Following numerous serious incidents resulting from medical devices (most notably, hip prostheses and defective silicone breast implants), a searchlight has been cast on the manufacturing, marketing, and surveillance of medical devices, as they stand in the EU. The systems in place contained many loopholes and shortcuts, which allowed some poor-quality and risk-compromising devices to be authorised. Consequently, the EU decided to tighten the regulatory procedures and two new EU regulations entered into force in 2017. They will apply, starting in 2020 and 2022, respectively. These changes set out in the regulations seek to improve medical device safety and performance and will carry consequences in terms of clinical evaluations and investigations on the devices, and how they are conducted. Switzerland is currently adapting its legislation on medical devices, to ensure that Swiss-based patients will also benefit from the improvements made. At the same time, only by aligning its own legislation to EU developments, will Switzerland be able to maintain its position as an equal partner in the EU internal market for medical devices. Nevertheless, some issues still need to be solved urgently for a smooth transition to take place.
{"title":"Medical devices: Regulatory environment forecasts","authors":"Mariagrazia Di Marco, Laure Vallotton","doi":"10.54920/scto.2019.rawatch.2.3","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.2.3","url":null,"abstract":"The regulatory landscape of medical devices is currently undergoing tremendous changes in the EU – changes that will directly affect Switzerland. Following numerous serious incidents resulting from medical devices (most notably, hip prostheses and defective silicone breast implants), a searchlight has been cast on the manufacturing, marketing, and surveillance of medical devices, as they stand in the EU. The systems in place contained many loopholes and shortcuts, which allowed some poor-quality and risk-compromising devices to be authorised. Consequently, the EU decided to tighten the regulatory procedures and two new EU regulations entered into force in 2017. They will apply, starting in 2020 and 2022, respectively. These changes set out in the regulations seek to improve medical device safety and performance and will carry consequences in terms of clinical evaluations and investigations on the devices, and how they are conducted. Switzerland is currently adapting its legislation on medical devices, to ensure that Swiss-based patients will also benefit from the improvements made. At the same time, only by aligning its own legislation to EU developments, will Switzerland be able to maintain its position as an equal partner in the EU internal market for medical devices. Nevertheless, some issues still need to be solved urgently for a smooth transition to take place.","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115386697","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 : 2019-04-01DOI: 10.54920/scto.2019.rawatch.1.2
{"title":"The European General Data Protection Regulation (GDPR): Interactions with clinical research","authors":"","doi":"10.54920/scto.2019.rawatch.1.2","DOIUrl":"https://doi.org/10.54920/scto.2019.rawatch.1.2","url":null,"abstract":"","PeriodicalId":419230,"journal":{"name":"Regulatory Affairs Watch","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133906981","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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