MHRA

WHAT IS MDR?

MHRA

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for the MDR.

If you manufacture custom-made dental appliances such as fixed bridges, bleaching trays, crowns, splints, retainers, you are required by the Medical Devices Regulations (MDR) to register with the Medicines and Healthcare Products Regulatory Agency (MHRA), and provide your business address and a description of the devices you produce. Read more about how to register your custom-made dental devices on the mhra.gov.uk website.

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

We reinforce 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 advises 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

MDR

MEDICAL DEVICES REGULATIONS 2021

Watch the video to find out more about the new Medical Devices Regulations (MDR) and the steps you need to take to comply.

DTA members can download MDR support materials including a factsheet and statement template for MDR in the members area here: https://www.dta-uk.org/guidance-documents .

MORE ABOUT MDR

The original framework for medical devices, which consisted of the Medical Devices Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC, has been amended. These directives have now been combined under the Medical Devices Regulations (MDR).

The new MDR regulations will be fully implemented by 26 May 2021 and effects all manufacturers and prescribing clinicians. This has been delayed by one year due to the COVID-19 pandemic. Currently, devices can be placed on the market under the current Medical Devices Directive (MDD) however, devices placed on the market from 26 May 2021 will need to fully comply with the MDR.

One of the main changes from May 2021 is that you will need to produce a Statement of Manufacture for each device you make and it is a legal requirement that the patient is offered a copy of the Statement of Manufacture. Keep a record of whether your patient accepts a copy and if they don't you should keep the Statement for the lifetime of the device.

The Statement of Manufacture has to provide a description of the appliance, state that it is made for a specific patient and show the name and address of the manufacturer. All appliances have to be signed off as fit for purpose by an appropriate qualified person.

The MHRA is responsible for enforcing the MDR but the GDC has said it will take action against dental professionals who don't meet their legal responsibilities.

FOR DTA MEMBERS

MDR INFORMATION 

The DTA provide members with regular updates, fact sheets, templates and guidance documents on the new MDR changes which you can view in the DTA Members area. Login now.