Editorial
Author
Joint secretary of the Ethics Council and the National Committee on Health Research Ethics, Copenhagen, Denmark
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2. European Commission. Regulation (EU) 2017/745 of the
European Parliament and of the Council of 5 April 2017
on Medical Devices, Amending Directive 2001/83/EC,
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1223/2009 and Repealing Council Directives 90/385/EEC and
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3. European Commission. Regulation (EU) 2017/746 of the European
Parliament and of the Council of 5 April 2017 on In vitro
Diagnostic Medical Devices and Repealing Directive 98/79/EC
and Commission. Available from: https://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX:32017R0746&from=EN.
4. European Court of Justice. Case c-329/16. Snitem and Philips
France. Available from: http://curia.europa.eu/juris/liste.
jsf?language=en&num=C-329/16.
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Europe: Implications for patients’ informed consent and liability.
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7. Ursenbach J, O’Connell ME, Neiser J, Tierney MC, Morgan D,
Kosteniuk J. et al. Scoring algorithms for a computer-based
cognitive screening tool: An illustrative example of overfitting
machine learning approaches and the impact on estimates of
classification accuracy. Psychol Assess 2019;31:1377-82.
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