{"id":"https://openalex.org/W4214546695","doi":"https://doi.org/10.5220/0010968600003123","title":"Analysis of Impact of European Medical Device Regulation and Brexit on the Regulatory Approaches in a Clinical Investigation Study on a New Class III Medical Devices Conducted in Europe and United Kingdom","display_name":"Analysis of Impact of European Medical Device Regulation and Brexit on the Regulatory Approaches in a Clinical Investigation Study on a New Class III Medical Devices Conducted in Europe and United Kingdom","publication_year":2022,"publication_date":"2022-01-01","ids":{"openalex":"https://openalex.org/W4214546695","doi":"https://doi.org/10.5220/0010968600003123"},"language":"en","primary_location":{"id":"doi:10.5220/0010968600003123","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0010968600003123","pdf_url":null,"source":{"id":"https://openalex.org/S4363608833","display_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.5220/0010968600003123","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5065757628","display_name":"Candice Houg","orcid":null},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I4210087978","display_name":"Centre Hospitalier Universitaire de Besan\u00e7on","ror":"https://ror.org/0084te143","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I4210087978"]},{"id":"https://openalex.org/I4210167250","display_name":"French Clinical Research Infrastructure Network","ror":"https://ror.org/05xw0wj25","country_code":"FR","type":"facility","lineage":["https://openalex.org/I4210167250","https://openalex.org/I4405258862"]}],"countries":["FR"],"is_corresponding":true,"raw_author_name":"Candice Houg","raw_affiliation_strings":["Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","Tech4Health network - FCRIN, France, --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210087978","https://openalex.org/I154526488"]},{"raw_affiliation_string":"Tech4Health network - FCRIN, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210167250"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5058961383","display_name":"Thomas Lihoreau","orcid":"https://orcid.org/0000-0001-8417-6609"},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I4210087978","display_name":"Centre Hospitalier Universitaire de Besan\u00e7on","ror":"https://ror.org/0084te143","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I4210087978"]},{"id":"https://openalex.org/I4210167250","display_name":"French Clinical Research Infrastructure Network","ror":"https://ror.org/05xw0wj25","country_code":"FR","type":"facility","lineage":["https://openalex.org/I4210167250","https://openalex.org/I4405258862"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Thomas Lihoreau","raw_affiliation_strings":["Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","Tech4Health network - FCRIN, France, --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210087978","https://openalex.org/I154526488"]},{"raw_affiliation_string":"Tech4Health network - FCRIN, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210167250"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082659686","display_name":"Martina Hennessy","orcid":"https://orcid.org/0000-0002-2153-5288"},"institutions":[{"id":"https://openalex.org/I205274468","display_name":"Trinity College Dublin","ror":"https://ror.org/02tyrky19","country_code":"IE","type":"education","lineage":["https://openalex.org/I205274468"]},{"id":"https://openalex.org/I4210154619","display_name":"St. James's Hospital","ror":"https://ror.org/04c6bry31","country_code":"IE","type":"healthcare","lineage":["https://openalex.org/I4210154619"]}],"countries":["IE"],"is_corresponding":false,"raw_author_name":"Martina Hennessy","raw_affiliation_strings":["Wellcome-HRB Clinical Research Facility, St James\u2019s Hospital and School of Medicine Trinity College Dublin,  Dublin, Ireland , --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Wellcome-HRB Clinical Research Facility, St James\u2019s Hospital and School of Medicine Trinity College Dublin,  Dublin, Ireland , --- Select a Country ---","institution_ids":["https://openalex.org/I4210154619","https://openalex.org/I205274468"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029435774","display_name":"H\u00e9l\u00e8ne Esp\u00e9rou","orcid":"https://orcid.org/0000-0002-1654-4868"},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Helene Esperou","raw_affiliation_strings":["Clinical Research Unit, National Institute of Health and Medical Research, Paris, France , --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Clinical Research Unit, National Institute of Health and Medical Research, Paris, France , --- Select a Country ---","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072934006","display_name":"Rachel Benamore","orcid":"https://orcid.org/0000-0001-7186-2677"},"institutions":[{"id":"https://openalex.org/I40120149","display_name":"University of Oxford","ror":"https://ror.org/052gg0110","country_code":"GB","type":"education","lineage":["https://openalex.org/I40120149"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Rachel Benamore","raw_affiliation_strings":["Department of Radiology, Oxford University Hospital Trust, Oxford, U.K., --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Department of Radiology, Oxford University Hospital Trust, Oxford, U.K., --- Select a Country ---","institution_ids":["https://openalex.org/I40120149"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034165070","display_name":"Jean Palussi\u00e8re","orcid":null},"institutions":[{"id":"https://openalex.org/I4210134409","display_name":"Institut Bergoni\u00e9","ror":"https://ror.org/02yw1f353","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I4210134409"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Jean Palussiere","raw_affiliation_strings":["Department of Interventional Radiology, Bergonie Institute, Bordeaux, France, --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Department of Interventional Radiology, Bergonie Institute, Bordeaux, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210134409"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5027872168","display_name":"Lionel Pazart","orcid":"https://orcid.org/0000-0002-9104-0862"},"institutions":[{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I4210087978","display_name":"Centre Hospitalier Universitaire de Besan\u00e7on","ror":"https://ror.org/0084te143","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I4210087978"]},{"id":"https://openalex.org/I4210167250","display_name":"French Clinical Research Infrastructure Network","ror":"https://ror.org/05xw0wj25","country_code":"FR","type":"facility","lineage":["https://openalex.org/I4210167250","https://openalex.org/I4405258862"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Lionel Pazart","raw_affiliation_strings":["Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","Tech4Health network - FCRIN, France, --- Select a Country ---"],"affiliations":[{"raw_affiliation_string":"Centre Hospitalier Universitaire de Besan\u00e7on, Centre d'Investigation Clinique,  INSERM CIC 1431, 25030, Besan\u00e7on, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210087978","https://openalex.org/I154526488"]},{"raw_affiliation_string":"Tech4Health network - FCRIN, France, --- Select a Country ---","institution_ids":["https://openalex.org/I4210167250"]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":7,"corresponding_author_ids":["https://openalex.org/A5065757628"],"corresponding_institution_ids":["https://openalex.org/I154526488","https://openalex.org/I4210087978","https://openalex.org/I4210167250"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.03591682,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"250","last_page":"258"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9598000049591064,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9598000049591064,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.9412999749183655,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.9387999773025513,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/brexit","display_name":"Brexit","score":0.8929235935211182},{"id":"https://openalex.org/keywords/class","display_name":"Class (philosophy)","score":0.5880981087684631},{"id":"https://openalex.org/keywords/world-class","display_name":"World class","score":0.4952479898929596},{"id":"https://openalex.org/keywords/medical-device","display_name":"Medical device","score":0.4694478213787079},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.4054223299026489},{"id":"https://openalex.org/keywords/international-trade","display_name":"International trade","score":0.35260576009750366},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.335342139005661},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.2602269649505615},{"id":"https://openalex.org/keywords/engineering","display_name":"Engineering","score":0.22552087903022766},{"id":"https://openalex.org/keywords/european-union","display_name":"European union","score":0.14887389540672302},{"id":"https://openalex.org/keywords/artificial-intelligence","display_name":"Artificial intelligence","score":0.1378765106201172},{"id":"https://openalex.org/keywords/manufacturing-engineering","display_name":"Manufacturing engineering","score":0.11781144142150879},{"id":"https://openalex.org/keywords/biomedical-engineering","display_name":"Biomedical engineering","score":0.07558399438858032}],"concepts":[{"id":"https://openalex.org/C2776469822","wikidata":"https://www.wikidata.org/wiki/Q7888194","display_name":"Brexit","level":3,"score":0.8929235935211182},{"id":"https://openalex.org/C2777212361","wikidata":"https://www.wikidata.org/wiki/Q5127848","display_name":"Class (philosophy)","level":2,"score":0.5880981087684631},{"id":"https://openalex.org/C2994232186","wikidata":"https://www.wikidata.org/wiki/Q50324608","display_name":"World class","level":2,"score":0.4952479898929596},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.4694478213787079},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4054223299026489},{"id":"https://openalex.org/C155202549","wikidata":"https://www.wikidata.org/wiki/Q178803","display_name":"International trade","level":1,"score":0.35260576009750366},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.335342139005661},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.2602269649505615},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.22552087903022766},{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.14887389540672302},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.1378765106201172},{"id":"https://openalex.org/C117671659","wikidata":"https://www.wikidata.org/wiki/Q11049265","display_name":"Manufacturing engineering","level":1,"score":0.11781144142150879},{"id":"https://openalex.org/C136229726","wikidata":"https://www.wikidata.org/wiki/Q327092","display_name":"Biomedical engineering","level":1,"score":0.07558399438858032}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.5220/0010968600003123","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0010968600003123","pdf_url":null,"source":{"id":"https://openalex.org/S4363608833","display_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"}],"best_oa_location":{"id":"doi:10.5220/0010968600003123","is_oa":true,"landing_page_url":"https://doi.org/10.5220/0010968600003123","pdf_url":null,"source":{"id":"https://openalex.org/S4363608833","display_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Proceedings of the 15th International Joint Conference on Biomedical Engineering Systems and Technologies","raw_type":"proceedings-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/17","display_name":"Partnerships for the goals","score":0.47999998927116394}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2979683410","https://openalex.org/W2914690430","https://openalex.org/W4240114703","https://openalex.org/W4319601116","https://openalex.org/W2921963337","https://openalex.org/W2560066009","https://openalex.org/W2559860852","https://openalex.org/W4383117548","https://openalex.org/W4386279425","https://openalex.org/W2492618015"],"abstract_inverted_index":null,"counts_by_year":[],"updated_date":"2026-04-17T18:11:37.981687","created_date":"2025-10-10T00:00:00"}
