DTA Emphasises Compliance with MHRA Medical Device Regulations for Custom-Made Dental Devices

We are reinforcing the importance of compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) Medical Device Regulations (MDR) for custom-made dental devices. This initiative aims to ensure that all dental appliances are safe, effective, and meet the highest standards of quality.

Key Highlights:

We underscore that only General Dental Council (GDC) registered dental technicians are authorised to sign off custom-made dental devices as fit for the marketplace. This requirement is crucial as these devices are intended for use in patients' bodies, necessitating rigorous standards and thorough knowledge of the manufacturing process and materials used.

The MHRA is responsible for enforcing the MDR, and the GDC has stated that it will take action against dental professionals who fail to meet their legal responsibilities. Manufacturers are advised to reference the MHRA MDR and the GDC document 'Standards for the Dental Team,' particularly sections 9.1 and 9.2.

We disagree with the notion that Laboratory Assistants and Dental Nurses can sign off custom-made dental devices. The association refers to the GDC document 'Standards for the Dental Team,' emphasising sections 1.3, 1.7, and 1.9.

Supporting the UK Market:

We strongly advise against importing custom-made dental devices from overseas. It is impossible for individuals to know how devices manufactured overseas are made or the materials used, and therefore, they cannot sign off a product as fit for purpose. The liability lies with the UK GDC registrant. By supporting the UK market, we ensure that all dental devices meet the stringent standards set by the MHRA and work to the GDCs remit to protect the public, thereby safeguarding patient health and safety.