{"id":"https://openalex.org/W7123328449","doi":"https://doi.org/10.6084/m9.figshare.31046283","title":"Regulatory readiness for innovation: a mixed-methods study of national competent authority professional and organizational capacities in the context of pre-market clinical investigations and early feasibility studies","display_name":"Regulatory readiness for innovation: a mixed-methods study of national competent authority professional and organizational capacities in the context of pre-market clinical investigations and early feasibility studies","publication_year":2026,"publication_date":"2026-01-12","ids":{"openalex":"https://openalex.org/W7123328449","doi":"https://doi.org/10.6084/m9.figshare.31046283"},"language":"en","primary_location":{"id":"doi:10.6084/m9.figshare.31046283","doi":"https://doi.org/10.6084/m9.figshare.31046283","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31046283","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.6084/m9.figshare.31046283","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5119829462","display_name":"Majella Geraghty","orcid":"https://orcid.org/0009-0007-9596-410X","observed_orcids":["https://orcid.org/0009-0007-9596-410X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Geraghty, Majella","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083810753","display_name":"Francesco Benito Malandrini","orcid":"https://orcid.org/0000-0002-0245-9849","observed_orcids":["https://orcid.org/0000-0002-0245-9849"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Malandrini, Francesco","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005724510","display_name":"Giuditta Callea","orcid":"https://orcid.org/0000-0002-7178-3781","observed_orcids":["https://orcid.org/0000-0002-7178-3781"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Callea, Giuditta","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5122344809","display_name":"Ali McDonnell","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"McDonnell, Ali","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5025432000","display_name":"Nicolas Martelli","orcid":"https://orcid.org/0000-0001-5959-231X","observed_orcids":["https://orcid.org/0000-0001-5959-231X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Martelli, Nicolas","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5065752937","display_name":"Ornella Tangila Kayembe","orcid":"https://orcid.org/0009-0009-3743-6178","observed_orcids":["https://orcid.org/0009-0009-3743-6178"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Kayembe, Ornella Tangila","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5122801585","display_name":"Sebastian Kuhn","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Kuhn, Sebastian","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5115630096","display_name":"Alexandra Herborg Cornelius Poulsson","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Poulsson, Alexandra Herborg Cornelius","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5122303649","display_name":"Tom Melvin","orcid":"https://orcid.org/0000-0001-6370-4177","observed_orcids":["https://orcid.org/0000-0001-6370-4177"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Melvin, Tom","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.01714116,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"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/T13417","display_name":"Biomedical Ethics and Regulation","score":0.0035000001080334187,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12185","display_name":"Regulation and Compliance Studies","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/3321","display_name":"Public Administration"},"field":{"id":"https://openalex.org/fields/33","display_name":"Social Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/national-competent-authorities","display_name":"national competent authorities","score":0.843999981880188},{"id":"https://openalex.org/keywords/eu-medical-device-regulation","display_name":"EU Medical Device Regulation","score":0.7120000123977661},{"id":"https://openalex.org/keywords/regulatory-capacity","display_name":"regulatory capacity","score":0.6309999823570251},{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.7020000219345093},{"id":"https://openalex.org/keywords/digital-health-technologies","display_name":"digital health technologies","score":0.824999988079071},{"id":"https://openalex.org/keywords/emerging-technologies","display_name":"emerging technologies","score":0.7689999938011169}],"concepts":[{"id":"https://openalex.org/C2777042776","wikidata":"https://www.wikidata.org/wiki/Q4583103","display_name":"Preparedness","level":2,"score":0.694100022315979},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.6467999815940857},{"id":"https://openalex.org/C56666940","wikidata":"https://www.wikidata.org/wiki/Q788790","display_name":"Documentation","level":2,"score":0.6407999992370605},{"id":"https://openalex.org/C2776436953","wikidata":"https://www.wikidata.org/wiki/Q5163215","display_name":"Consistency (knowledge bases)","level":2,"score":0.5903000235557556},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.5701000094413757},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.450300008058548},{"id":"https://openalex.org/C509550671","wikidata":"https://www.wikidata.org/wiki/Q126945","display_name":"Medical education","level":1,"score":0.4278999865055084},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.39879998564720154},{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.3882000148296356},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.37869998812675476},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.35409998893737793},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.3107999861240387},{"id":"https://openalex.org/C55587333","wikidata":"https://www.wikidata.org/wiki/Q1133029","display_name":"Engineering ethics","level":1,"score":0.305400013923645},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.2786000072956085},{"id":"https://openalex.org/C3019806175","wikidata":"https://www.wikidata.org/wiki/Q11974939","display_name":"Health professionals","level":3,"score":0.27639999985694885},{"id":"https://openalex.org/C65067816","wikidata":"https://www.wikidata.org/wiki/Q2295139","display_name":"Computer-assisted web interviewing","level":2,"score":0.2727999985218048},{"id":"https://openalex.org/C134215751","wikidata":"https://www.wikidata.org/wiki/Q829080","display_name":"Professional association","level":2,"score":0.27129998803138733},{"id":"https://openalex.org/C148220186","wikidata":"https://www.wikidata.org/wiki/Q7111912","display_name":"Outcome (game theory)","level":2,"score":0.26809999346733093},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.26030001044273376},{"id":"https://openalex.org/C51067260","wikidata":"https://www.wikidata.org/wiki/Q828812","display_name":"Professional development","level":2,"score":0.2540999948978424}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.6084/m9.figshare.31046283","doi":"https://doi.org/10.6084/m9.figshare.31046283","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31046283","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},{"id":"doi:10.6084/m9.figshare.31046283.v1","doi":"https://doi.org/10.6084/m9.figshare.31046283.v1","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31046283.v1","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"}],"best_oa_location":{"id":"doi:10.6084/m9.figshare.31046283","doi":"https://doi.org/10.6084/m9.figshare.31046283","is_oa":true,"landing_page_url":"https://doi.org/10.6084/m9.figshare.31046283","pdf_url":null,"source":{"id":"https://openalex.org/S4377196282","display_name":"Figshare","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4210132348","host_organization_name":"Figshare (United Kingdom)","host_organization_lineage":["https://openalex.org/I4210132348"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"JournalArticle"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8371999859809875,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4417479645","https://openalex.org/W7165539574","https://openalex.org/W7167264040","https://openalex.org/W7203825852","https://openalex.org/W4280491542","https://openalex.org/W4412442986","https://openalex.org/W4405749350","https://openalex.org/W7133312190","https://openalex.org/W7166114711","https://openalex.org/W7163724948"],"abstract_inverted_index":{"Early":[0],"Feasibility":[1],"Studies":[2],"(EFS)":[3],"support":[4],"early-stage":[5],"evaluation":[6],"of":[7,71,98,130,143,169],"novel":[8],"technologies.":[9,81],"Under":[10],"the":[11,96,167,173],"European":[12],"Union":[13],"Medical":[14],"Device":[15],"Regulation":[16],"(EU":[17],"MDR":[18],"2017/745),":[19],"National":[20],"Competent":[21],"Authorities":[22],"(NCAs)":[23],"assess":[24,38,87],"these":[25],"investigations.":[26],"However,":[27],"little":[28],"is":[29,93,156],"known":[30],"about":[31],"their":[32],"organizational":[33],"readiness":[34,89],"and":[35,44,56,77,90,102,116,122,132,141,162,179,191],"ability":[36],"to":[37,86,152,187],"complex":[39],"technologies":[40],"in":[41,95,106,111,128,159],"a":[42],"consistent":[43],"coordinated":[45],"manner.":[46],"A":[47],"mixed-methods":[48],"study":[49],"was":[50,139],"conducted":[51],"via":[52],"an":[53],"online":[54],"survey":[55],"virtual":[57],"workshop":[58],"involving":[59],"23":[60],"NCAs.":[61],"Outcome":[62],"measures":[63],"included":[64],"assessor":[65,160],"assignment":[66],"models,":[67],"qualifications,":[68],"training,":[69],"use":[70,142],"external":[72,144],"experts,":[73],"sponsor":[74,181],"dialogue":[75,182],"mechanisms,":[76],"preparedness":[78,190],"for":[79],"emerging":[80],"Data":[82],"were":[83,109,126],"thematically":[84],"analyzed":[85],"systemic":[88],"capacity.":[91],"There":[92,155],"variability":[94,158],"documentation":[97],"clinical":[99],"investigation":[100],"phases":[101],"assessment":[103],"practices.":[104,163],"Gaps":[105],"NCA":[107],"resources":[108],"notable":[110],"digital":[112],"health":[113],"technology":[114],"(DHTs)":[115],"artificial":[117],"intelligence-enabled":[118],"medical":[119],"devices":[120],"(AIeMD)":[121],"statistics.":[123],"Dialogue":[124],"mechanisms":[125,183],"present":[127],"63%":[129],"NCAs":[131,147],"associated":[133],"with":[134],"improved":[135],"submission":[136],"quality.":[137],"Training":[138],"fragmented":[140],"experts":[145],"limited.":[146],"emphasized":[148],"regulatory":[149,170,189],"strain":[150],"due":[151],"rising":[153],"complexity.":[154],"significant":[157],"qualifications":[161],"These":[164],"differences":[165],"limit":[166],"consistency":[168],"oversight":[171],"under":[172],"MDR.":[174],"Establishing":[175],"structured":[176],"training":[177],"programs,":[178],"harmonized":[180],"will":[184],"be":[185],"critical":[186],"supporting":[188],"coherence.":[192]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2026-01-13T00:00:00"}
