Overview
Dental materials, instruments and equipment used in clinical practice are classified as medical devices and are subject to a defined regulatory framework to ensure that they are safe, effective and for their intended purpose. They must meet recognised standards before they can be placed on the market or used in your practice. These requirements apply across all UK nations, although there are important distinctions in how the rules operate depending on the nation you practice in. As a dental professional, understanding these requirements is an essential part of maintaining compliance and ensuring the safety of your patients.
Depending on the relevant jurisdiction and the date of manufacture, devices may carry one of several different marks to provide assurance that a product has been assessed against the relevant safety and performance standards.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the authority responsible for regulating medical devices in the UK. It oversees compliance, investigates safety concerns, and hold enforcement powers in cases where standards are not met. You should be confident that the devices you use meet the required standards and are sourced from reputable manufacturers or suppliers.
In addition to manufactured devices, dentists frequently prescribe custom-made medical devices, which are also subject to regulatory requirements. These devices are covered by the directive, so you must check with your laboratory that they are registered with the MHRA and follow the required manufacturing procedures. A statement of manufacture confirming this should accompany each custom-made device.
You must also be prepared to manage issues where equipment is defective or fails. This includes taking appropriate action to report concerns with medical devices. Our advice on CQC compliance requirements also contains more information on what you will need to demonstrate when you are inspected.
