Medical devices: From directives to regulations

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.

from$8.99

All prices are NET prices.

References

  1. 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. 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. 3.

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

  4. 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. 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. 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.

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Christina Williams.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

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

Download citation

Search