MHRA

WHAT IS MDR?

MHRA

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

What is the MHRA?

The MHRA (Medicines and Healthcare products Regulatory Agency) is the UK government agency responsible for ensuring that medicines, medical devices (including custom-made dental devices), and blood components for transfusion meet applicable safety, quality, and efficacy standards. It regulates and monitors products to protect public health, oversees compliance with UK law, and provides guidance to manufacturers and healthcare professionals. In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for the MDR.

What is the UK Medical Devices Regulations (MDR)?

The UK Medical Devices Regulations (UK MDR) are the legal framework governing the manufacture, supply, and use of custom-made dental devices in Great Britain. They set requirements for device safety, performance, labeling, clinical evaluation, and post-market surveillance. The regulations implement UK-specific rules following the UK's exit from the EU, aligning closely with previous EU Medical Device Regulations while incorporating modifications relevant to the UK market.

Who must register with the MHRA?

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

New Annual MHRA Device Registration Fees (from April 2026)

From 1 April 2026, the MHRA is introducing a new annual registration fee for medical device manufacturers based on the number of Global Medical Device Nomenclature (GMDN) Level 2 Categories under which devices are registered. This replaces the previous one-off registration fee and will be payable each year.

  • Estimated cost is around £300 per registered GMDN Level 2 category per year.
  • Only one annual fee is charged per relevant Level 2 Category, even if multiple devices fall under that category.
  • Final fees will be confirmed based on registrations as at 31 March each year.

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 

We provide additional practical tools, templates, updates, and guidance documents on MHRA's MDR. Members can access these in the Guidance Documents section.

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