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Medical devices: From directives to regulations

BDJ Student volume 27, pages 20–22 (2020)Cite this article

By Christina Williams, Foundation Dentist

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References

  1. European Parliament, Council 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. Online information available at: http://data.europa.eu/eli/reg/2017/745/oj (accessed: February 2020).

  2. European Parliament, Council of the European Union. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Online information available at: http://data.europa.eu/eli/dir/1993/42/oj (Accessed June 2020).

  3. Frumento C. French breast implants, The Medical Device Regulation, and a theoretical case study. Med Writing 2017; 26: 39-40.

  4. General Dental Council. Guidance on commissioning and manufacturing dental appliances. Online information available at: https://www.gdc-uk.org/information-standards-guidance/standards-and-guidance/gdc-guidance-for-dental-professionals/guidance-documents (accessed: February 2020).

  5. Medicines and Healthcare Products Regulatory Authority. Custom-made devices. Online information available at: https://www.gov.uk/government/publications/custom-made-medical-devices (accessed: February 2020).

  6. Loh E and Boumans R. Understanding Europe's New Medical Devices Regulation (MDR 2017/745) New requirements, key changes, and transition strategies for device companies. Austin: Emergo, July 2018.

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  1. Gwena Dental Care, 106 Maes-y-Coed Road, CF14 4HH, Cardiff, UK

    Christina Williams

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  1. Christina Williams
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Correspondence to Christina Williams.

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Williams, C. Medical devices: From directives to regulations. BDJ Student 27, 20–22 (2020). https://doi.org/10.1038/s41406-020-0141-y

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  • DOI: https://doi.org/10.1038/s41406-020-0141-y

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