Are you compliant with the MHRA’s registration requirements? Pat Langley uncovers what you need to know.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. Dental laboratories are required to register with the MHRA, and you should check that the laboratory/laboratories you use is/are registered.
Many/most dental practices will know that they should register with the MHRA to ensure they receive updates from them for example when an alert goes out about an item, drug, or piece of equipment that has been recalled. What you may not know though is the other requirements relating to the MHRA and dental practices.
Being faced with a CQC inspection can be a worrying time for any dental practice. Having a compliance management system in place can go a long way towards making sure you and your team are as prepared as possible, helping to ease some of the stress.
Dentistry Compliance is a complete end-to-end management solution that simplifies and integrates compliance into your daily business processes seamlessly, ensuring your practice meets current professional standards. For more information or to book a free demo, visit www.dentistry.co.uk/compliance.
Dental practices that manufacture custom-made dental appliances are required by the Medical Devices Directive 93/42/EEC (MDD) to register with the MHRA and provide a business address and a description of the devices produced. The UK Medical Devices Directive defines a custom-made device as one that has been made or manufactured to the written prescription of a registered dental practitioner for the sole use of a particular named patient.
In addition to applying to dental laboratories, this also applies if you create medical devices in the practice, for example, milled restorations or retainers. A failure to register with the MHRA when required to do so may place you at risk of incurring a fine. The General Dental Council (GDC), the CQC, and the regulators in the devolved nations all expect registrants and practices to comply with the MHRA’s registration requirements so you may be asked about this at a regulatory inspection.
MHRA guidance and legislation
The MHRA’s guidance is divided into sections with different rules applying in Great Britain, Northern Ireland, and the EU. (Please note: Great Britain is England, Wales, and Scotland). Guidance for Great Britain can be found on www.gov.uk.
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. The MHRA has introduced legislation to supplement provisions that were introduced in Northern Ireland on 26 May 2021 when the EU Medical Devices Regulation (2017/745) (EU MDR) took effect. This legislation has introduced a requirement to register all custom-made devices with the MHRA within 28 days of being made available on the Northern Ireland market.
What do you need to do?
- Check that the dental laboratory/laboratories you use is/are registered
- Check that the technicians working at the laboratory/laboratories you use are all registered with the GDC
- Register with the MHRA if your practice provides custom-made medical devices (that are made at your practice) directly to specific, named patients
- Provide a business address and a description of the devices produced
- Re-register with the MHRA after two years
- Comply with the MHRA’s requirements for custom-made medical devices
- Ensure all custom-made medical devices you provide to patients, whether they are manufactured by a laboratory or made in the practice have a written prescription
- Provide a Patient Statement of Manufacture for all custom-made medical devices you provide to patients, whether they are manufactured by a laboratory or made in the practice. It is good practice to offer the Statement of Manufacture to the patient. If they decline you should record the fact that it was offered to the patient and declined in their dental record and either keep the paper version if you keep paper patient records or scan and upload it into the patient’s electronic record. If your patient accepts the Statement, record this too.
Written prescription and Patient Statement
Laboratories usually provide a written prescription pad for their clients to help ensure all the required details are clearly recorded. Some laboratories combine the patient prescription with the Patient Statement in a second part of the form. Whether the two forms are combined or separate, the following should always be recorded:
- Patient’s name or identification number or code
- Name of the prescriber
- Practice name and address
- Date the work was sent and the date it is required
- Type of appliance and materials to be used
- Outline of the design
- Instructions to the technician.
The Patient Statement should state the following, or something similar with the same meaning: ‘This is a custom-made medical device that has been manufactured to satisfy the design characteristics and properties specified by the prescriber for the above-named patient. This medical device is intended for exclusive use by this patient and conforms to the relevant essential requirements.’
Practices that have patients with custom-made medical devices that are made in the practice should modify the wording accordingly. The Patient Statement should also state that the device was wholly manufactured in the UK.
A nominated UK Responsible Person is required for laboratory work manufactured outside the UK.
Fulfil all your compliance requirements with Dentistry Compliance. Visit dentistry.co.uk/compliance for more information and to sign up.
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