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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

On 26 May 2021 new medical device regulations (MDR) governing the entire supply chain for medical devices, including the responsibilities for healthcare professionals, comes into full effect.1 Any manufacturer of dental appliances, whether a dental technician, dentist or other registrant is legally bound to comply, but the legislation is long and complex and the subtleties between the new regulations and previous medical device directives (MDD) are not entirely obvious.2 Guidance from health authorities in itself is demanding, and there is a definite space for a summary specific to the dental profession.

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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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