The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation

Authors

  • Sílvia Rêgo Fraunhofer Portugal AICOS (Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions). Porto; Faculdade de Medicina. Universidade do Porto. Porto.
  • Marco Dutra-Medeiros Department of Ophthalmology. Centro Hospitalar Universitário Lisboa Central. Lisbon; NOVA Medical School. Universidade NOVA de Lisboa. Lisbon; Portuguese Retina Institute. Lisbon. https://orcid.org/0000-0003-0421-1211
  • Francisco Nunes Fraunhofer Portugal AICOS (Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions). Porto. https://orcid.org/0000-0002-4913-9412

DOI:

https://doi.org/10.20344/amp.19423

Keywords:

Clinical Research, European Union, Medical Device Legislation

Abstract

N/a.

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References

European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. [cited 2022 Nov 17]. Available from: https://www.legislation.gov.uk/eur/2017/745/contents.

Healthskouts. FDA/CE certified health app database. 2022. [cited 2023 Jan 13]. Available from: https://www.healthskouts.com/certified-apps/.

Malvehy J, Ginsberg R, Sampietro-Colom L, Ficapal J, Combalia M, Svedenhag P. New regulation of medical devices in the EU: impact in dermatology. J Eur Acad Dermatol Venereol. 2022;36:360-4. DOI: https://doi.org/10.1111/jdv.17830

Central Committee on Research Involving Human Subjects. Investigational medical device dossier. 2020. [cited 2022 Nov 17]. Available from: https://english.ccmo.nl/investigators/publications/forms/2020/12/14/d2-imdd-template.

European Commission’s Medical Devices Coordination Group. MDCG 2021-6: Regulation (EU) 2017/745 – Questions & answers regarding clinical investigation. 2021. [cited 2022 Nov 17]. Available from: https://health.ec.europa.eu/system/files/2021-04/mdcg_2021-6_en_0.pdf.

Central Committee on Research Involving Human Subjects. Review of a clinical investigation with a medical device – guidance document for MRECs.

[cited 2022 Nov 17]. Available from: https://english.ccmo.nl/publications/publications/2021/05/17/review-of-a-clinical-investigation-with-a-medicaldevice-–-guidance-document-for-mrecs.

European Union. Directive 2021/20/EC of the European Parliament and of the Council of 4 April 2001. 2001. [cited 2022 Nov 17]. Available from: https://www.legislation.gov.uk/eudr/2001/20/introduction.

International Organization for Standardization. ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.2020. [cited 2022 Nov 20]. Available from: https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-3:v1:en.

Medical Device Directive. Council Directive 93/42/EEC of 14 June 1993 Concerning medical devices. 2017. [cited 2022 Nov 24]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042.

Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming clinical research in the United States: challenges and opportunities: workshop summary. Washington: National Academies Press; 2010.

Allianz Global Corporate & Specialty. Addressing the challenges of clinical trials insurance. 2022. [cited 2022 Nov 17]. Available from: https://www.agcs.allianz.com/news-and-insights/expert-risk-articles/addressing-challenges-clinical-trials-insurance.html.

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Published

2023-05-26

How to Cite

1.
Rêgo S, Dutra-Medeiros M, Nunes F. The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation. Acta Med Port [Internet]. 2023 May 26 [cited 2023 Sep. 25];36(7-8):455-7. Available from: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19423

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