Medical Device Regulations for custom-made devices: Answers to a further ten important questions-Reference-Cited by-同舟云学术

Medical Device Regulations for custom-made devices: Answers to a further ten important questions

Published:2024-01-19 Issue:1 Volume:11 Page:22-28
ISSN:2054-7617
Container-title:BDJ Team
language:en
Short-container-title:BDJ Team

Author:

Green James I. J.

Publisher

Springer Science and Business Media LLC

Link

https://www.nature.com/articles/s41407-024-2061-0.pdf

Reference22 articles.

1. Official Journal of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 14 June 1993. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN (accessed November 2023).

2. UK Government. The Medical Devices Regulations 2002. 20 May 2002. Available at: https://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (accessed November 2023).

3. Green J I J. The impact of medical device regulation on hospital doctors who prescribe and manufacture custom-made devices. Br J Hosp Med 2020; 81: doi: 10.12968/hmed.2020.0596.

4. European Parliament/European Council. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 5 April 2017. Available at: https://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 (accessed November 2023).

5. Official Journal of the European Union. Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions. 23 April 2020. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN (accessed November 2023).