Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions-Reference-Cited by-同舟云学术

Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions

Published:2023-08-11 Issue:3 Volume:235 Page:205-210
ISSN:0007-0610
Container-title:British Dental Journal
language:en
Short-container-title:Br Dent J

Author:

Green James I. J.

Publisher

Springer Science and Business Media LLC

Subject

General Dentistry

Link

https://www.nature.com/articles/s41415-023-6104-2.pdf

Reference22 articles.

1. Official Journal of the European Communities. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 1993. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN (accessed December 2022).

2. UK Government. The Medical Devices Regulations 2002. 2002. Available at https://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (accessed December 2022).

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 (Lond) 2020; 81: 1-6.

4. Official Journal of the European Union. 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. 2017. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 (accessed December 2022).

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. 2020. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN (accessed December 2022).