<?xml version="1.0" encoding="UTF-8"?> <!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2d1 20170631//EN" "JATS-journalpublishing1.dtd"> <ArticleSet> <Article> <Journal> <PublisherName>ijcicr</PublisherName> <JournalTitle>International Journal of Clinical Investigation and Case Reports</JournalTitle> <PISSN>C</PISSN> <EISSN>l</EISSN> <Volume-Issue>Volume 1, Issue 1</Volume-Issue> <PartNumber/> <IssueTopic>Multidisciplinary</IssueTopic> <IssueLanguage>English</IssueLanguage> <Season>(May-July)</Season> <SpecialIssue>N</SpecialIssue> <SupplementaryIssue>N</SupplementaryIssue> <IssueOA>Y</IssueOA> <PubDate> <Year>2022</Year> <Month>05</Month> <Day>9</Day> </PubDate> <ArticleType>Biomedical Science</ArticleType> <ArticleTitle>The New European Medical Device Regulation: Place of Surgeons in the Clinical Evaluation</ArticleTitle> <SubTitle/> <ArticleLanguage>English</ArticleLanguage> <ArticleOA>Y</ArticleOA> <FirstPage>1</FirstPage> <LastPage>6</LastPage> <AuthorList> <Author> <FirstName>Farid</FirstName> <LastName>Benabdallah*</LastName> <AuthorLanguage>English</AuthorLanguage> <Affiliation/> <CorrespondingAuthor>N</CorrespondingAuthor> <ORCID/> <FirstName>Hubert Johanet</FirstName> <LastName>(FRANCE)</LastName> <AuthorLanguage>English</AuthorLanguage> <Affiliation/> <CorrespondingAuthor>Y</CorrespondingAuthor> <ORCID/> </Author> </AuthorList> <DOI>10.55828/ijcicr-11-01</DOI> <Abstract>The new European medical devices regulations now require manufacturers to evaluate the devices used by surgeons over the long term, which is necessary both to support CE marking and marketing applications and to monitor their performance and safety. The adherence of the Health Care Professionals (HCP) to the clinical evaluation and to the studies is essential to deliver quality data, which supports the files of CE marking, and ultimately contributes to the innovation of health technologies.</Abstract> <AbstractLanguage>English</AbstractLanguage> <Keywords>Medical Devices Regulation,Clinical Evaluation,Applications,Ethical Issue, Surgeons</Keywords> <URLs> <Abstract>https://ijcicr.com/ubijournal-v1copy/journals/abstract.php?article_id=13708&title=The New European Medical Device Regulation: Place of Surgeons in the Clinical Evaluation</Abstract> </URLs> <References> <ReferencesarticleTitle>References</ReferencesarticleTitle> <ReferencesfirstPage>16</ReferencesfirstPage> <ReferenceslastPage>19</ReferenceslastPage> <References>European Union. Official Journal. EU MDR. 2017 Warck R, Jean T, Royer B, Cailleau M, Beverley B. Motivational survey on the participation of physicians in public health research. Santand;eacute; Publique. 2002;14(2):191-199. Adam P, Herzlich C, Singly DE. Sociology of disease and medicine. Nathan Paris: BSDP; 1994. Aiach P, Fassin D. Health professions. Power issues and the quest for legitimacy. Anthropos, Paris: 1994. Bouffechoux T. Health in France, the patient, the doctor and the State. Le Monde Editions. Paris: 1997. Herzlich C, Bungener M, Paicheler G, Roussin P, Zuber MC. Fifty years of medicine in France. Career and practices of French doctors (1930-1980). Les editions INSERM. France; 1993:274. Le Pen C. The new clothes of Hippocrates, from craftsman doctor to engineer doctor. Calmann Land;eacute;vy. Paris: 1999. Mercier-Penit S. Profile of investigators participating in a phase IIIb clinical trial in medicine general. About the Diabhycar study. Medicine thesis. Lyon I: 1997. Tchobroutsky G, Wong O. The profession of doctor. 2nd ed. Paris, PUF: 1996. Sumi E, Murayama T, Yokode M. A survey of attitudes toward clinical research among physicians at Kyoto University Hospital. BMC Medical Education. 2009;9(1):1-7. Desai M. Recruitment and retention of participants in clinical studies: Critical issues and challenges. Perspect Clin Res. 2020;11(2):51-53. Bose D, Saha S, Saxena U, Kesari H, Thatte UM, Gogtay NJ. Factors influencing recruitment and retention of participants in clinical studies conducted at a tertiary referral center: A five?year audit. Perspect Clin Res. 2020;11:81-85. Manneser DA, Moloney RM, Warrinner AH, Wright MC. Understanding practice-based research participation: The differing motivations of engaged vs. non-engaged clinicians in pragmatic clinical trials. Contemp Clin Trials Commun. 2016;15(4):136-40. Susanne F, Patricia E, Cornelia H. Physicians’ decision making on adoption of new technologies and role of coverage with evidence development: a qualitative study. Values in Health. 2018;21(9):1069-1076. Cockburn IM, Henderson RM. Absorptive capacity, coauthoring behavior, and the organization of research in drug discovery. The J of Industrial Economics.1998;46(2):157-182. Flamein R, Slim K. Evidence based surgery has some limitations. Annales de chirurgie. 2005; 130(9):541-546.</References> </References> </Journal> </Article> </ArticleSet>