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

Author:

Green James I. J.

Publisher

Springer Science and Business Media LLC

Subject

General Dentistry

Reference20 articles.

1. Council of the European Communities. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. 1990. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0385&from=EN (accessed September 2020).

2. Council 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 September 2020).

3. European Parliament/European Council. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 1998. Available at https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20090807:EN:PDF (accessed September 2020).

4. European Parliament/European Council. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. 2007. Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007L0047&from=en (accessed September 2021).

5. Statutory Instruments. The Medical Devices Regulations 2002. 2002. Available at https://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (accessed September 2020).

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