The European medical device regulation (2017/745): saving lives or stifling innovation?
Autor(a) principal: | |
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Data de Publicação: | 2021 |
Tipo de documento: | Dissertação |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10362/127591 |
Resumo: | The demand for medical products is increasing. However, their manufacturing and application are subject to regulation and certification processes. The aim of this thesis is to discuss the development of this industry in the context of the new Medical Device Regulation (MDR). Expert interviews from production, medical law, the field of medicine, including the university environment, are qualitatively evaluated on the basis of the theoretical concept of the relationship between regulation and innovation. Agreements and controversies about the intentions of the MDR are captured and possible reactions to the changing European legislation are depicted. |
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The European medical device regulation (2017/745): saving lives or stifling innovation?Medical device regulationMedical devicesHealthInnovationGermanyDomínio/Área Científica::Ciências Sociais::Economia e GestãoThe demand for medical products is increasing. However, their manufacturing and application are subject to regulation and certification processes. The aim of this thesis is to discuss the development of this industry in the context of the new Medical Device Regulation (MDR). Expert interviews from production, medical law, the field of medicine, including the university environment, are qualitatively evaluated on the basis of the theoretical concept of the relationship between regulation and innovation. Agreements and controversies about the intentions of the MDR are captured and possible reactions to the changing European legislation are depicted.Martins, Miguel AlvesRUNStrunz, Marie2024-01-04T01:30:55Z2021-01-112021-01-042021-01-11T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10362/127591TID:202738981enginfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:07:33Zoai:run.unl.pt:10362/127591Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:46:10.292918Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
title |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
spellingShingle |
The European medical device regulation (2017/745): saving lives or stifling innovation? Strunz, Marie Medical device regulation Medical devices Health Innovation Germany Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
title_short |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
title_full |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
title_fullStr |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
title_full_unstemmed |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
title_sort |
The European medical device regulation (2017/745): saving lives or stifling innovation? |
author |
Strunz, Marie |
author_facet |
Strunz, Marie |
author_role |
author |
dc.contributor.none.fl_str_mv |
Martins, Miguel Alves RUN |
dc.contributor.author.fl_str_mv |
Strunz, Marie |
dc.subject.por.fl_str_mv |
Medical device regulation Medical devices Health Innovation Germany Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
topic |
Medical device regulation Medical devices Health Innovation Germany Domínio/Área Científica::Ciências Sociais::Economia e Gestão |
description |
The demand for medical products is increasing. However, their manufacturing and application are subject to regulation and certification processes. The aim of this thesis is to discuss the development of this industry in the context of the new Medical Device Regulation (MDR). Expert interviews from production, medical law, the field of medicine, including the university environment, are qualitatively evaluated on the basis of the theoretical concept of the relationship between regulation and innovation. Agreements and controversies about the intentions of the MDR are captured and possible reactions to the changing European legislation are depicted. |
publishDate |
2021 |
dc.date.none.fl_str_mv |
2021-01-11 2021-01-04 2021-01-11T00:00:00Z 2024-01-04T01:30:55Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10362/127591 TID:202738981 |
url |
http://hdl.handle.net/10362/127591 |
identifier_str_mv |
TID:202738981 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799138066190827520 |