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Common dentolegal queries

  • Q
    Can you tell me if I need to register with the Medicines and Healthcare Products Regulatory Agency (MHRA) if I want to provide patients with Cerec restorations involving CAD/CAM technology?
    +
    05 February 2016

    The MHRA is an executive agency of the Department of Health that, amongst other responsibilities, it is responsible for ensuring that medical devices in the UK meet the applicable standards of safety, quality and efficacy. The agency also regulates medicines, and blood components for transfusion

    All “custom made devices” are subject to Medical Devices Directive (MDD) regulations, and that includes any device specifically made in accordance with a duly qualified medical or dental practitioner’s written prescription with specific design characteristics and intended for the sole use of a particular patient whether NHS or private.

    The Medical Devices Directive requires that manufactures of any dental device classed as a “custom made device”, such as a Cerec restoration, must register with the MHRA, providing them with a description of the devices concerned and the business address.

    A registration form can be downloaded from www.mhra.gov.uk

    The General Dental Council requires each registrant to be responsible for finding out about laws and regulations which affect their work premises, equipment and business.

    When producing Cerec restorations you must comply with the MDD regulations and as the prescriber of a “custom made device” it is important to ensure that the patient is made aware that they can request the statement of manufacture and to ensure that the document is made available to the patient if it is requested. Non-compliance with such an obligation is regarded as a criminal offence.

  • Q
    I am an experienced sedation practitioner. What do I need to consider following the introduction of the IACSD Standards document published in April 2015?
    +
    03 February 2016

    It is every General Dental Council registrant’s duty to ensure they are competent and have received adequate training for the tasks they are to perform. The GDC expects registrants to follow appropriate guidelines, in this case the Report of the Intercollegiate Advisory Committee for Sedation in Dentistry (IASCD) entitled Standards for Conscious Sedation and the Provision of Dental Care 2015

    • You should take the time necessary to really understand the new standards and how you will implement them in your provision of sedation services. In particular you need to consider whether you and your sedation nurses comply with the standards in terms of you being regarded as suitable as a sedation practitioner. This may mean exploring the transitional arrangements section.
    • You and your team will need to demonstrate either ILS training or a course which trains the essential components of ILS relevant to sedation dentistry. This training needs to be relevant to the age of the patients you will be treating. If you treat children under the age of 12, compliance with the equivalent to PILS would be expected.
    • You will need to provide sedation cases on a regular basis. No minimum limit is set but you need to consider whether you complete enough cases to maintain your skills and be able to comply with the standards.
    • Your nurse does not need to hold the NEBDN certificate but will be expected to demonstrate adequate training and experience
    • You need to complete regular audits of your sedation activity to demonstrate your commitment to improving the service you offer. As yet there are no "off the peg audits" to use, and you would be expected to tailor yours to your particular style of practice.

    It may be helpful to bear in mind the Standards have already undergone several modifications without notice so please ensure that you keep updated of any changes.

    If you require further advice, please contact us

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