DynamoDental

Medical Devices Regulations 2002 (SI 2002/618), as amended

Medical Devices Regulations: servicing and manufacturer instructions

In Great Britain, medical devices are regulated under the Medical Devices Regulations 2002, enforced by the MHRA. A device placed on the market must carry a UKCA or CE mark (subject to the transitional arrangements in force) and must come with instructions for use. Many items in a dental surgery are medical devices: the treatment centre and chair, handpieces, and equipment such as suction units and compressors supplied as part of a dental system.

Jurisdiction
England
Last verified
9 September 2026
Next review
9 March 2027
Version
1

In plain English

In Great Britain, medical devices are regulated under the Medical Devices Regulations 2002, enforced by the MHRA. A device placed on the market must carry a UKCA or CE mark (subject to the transitional arrangements in force) and must come with instructions for use. Many items in a dental surgery are medical devices: the treatment centre and chair, handpieces, and equipment such as suction units and compressors supplied as part of a dental system.

The regulations place most of their obligations on manufacturers. For the practice, the practical duties flow from elsewhere: the CQC's fundamental standards, PUWER and the manufacturer's instructions themselves. The manufacturer's instructions are the reference for how a device should be installed, used, maintained and repaired, and following them is how a practice shows that the device is being used as intended.

The MHRA also runs the Yellow Card scheme for reporting adverse incidents involving medical devices, and publishes guidance on managing medical devices for health and social care organisations.

Who does what

Your responsibility as the provider

  • Using devices for their intended purpose and in line with the manufacturer's instructions
  • Keeping the instructions for use and maintenance available for each device
  • Having devices maintained and repaired by people with the appropriate competence, using suitable parts
  • Reporting adverse incidents involving devices to the MHRA through the Yellow Card scheme, and to the CQC where the notification rules require it
  • Keeping records that identify each device (manufacturer, model, serial number) and its maintenance history
  • Responding to manufacturer field safety notices and MHRA alerts that apply to devices the practice holds

What Dynamo Dental delivers directly

Some manufacturers restrict particular work to their own trained agents. Where that applies to a device we are asked to work on, we say so and can help arrange it. Otherwise, for the devices we maintain:

  • Servicing and repairing chairs and treatment units, compressors, suction systems and amalgam separators in line with the manufacturer's maintenance instructions
  • Installing and commissioning equipment as the manufacturer's installation instructions describe, and recording it
  • Using parts that are suitable for the device, and stating on the report which parts were fitted
  • Recording manufacturer, model and serial number for each device we work on, so the practice's asset register can be matched against safety notices
  • Providing the engineering facts the practice needs if it decides to report an incident

Verified specialist competence, or a specialist partner

  • Work a manufacturer reserves for its own service organisation: the manufacturer or its appointed agent
  • Devices outside our categories (radiography, decontamination, lasers, electrosurgery): the relevant specialist
  • Deciding whether an incident is reportable: the practice, using MHRA guidance
  • Any modification to a device: normally only with the manufacturer's agreement, because modification can affect its status as a medical device

Outside our scope

  • Claiming approval or authorisation by a manufacturer that has not been confirmed in writing
  • Certifying that a device conforms to the regulations
  • Regulatory advice on placing devices on the market
  • Modifying devices outside the manufacturer's instructions

Questions

Questions on this topic

Do we have to use the manufacturer for servicing?

The regulations do not say who may service a device; they require it to be maintained as the manufacturer instructs. Some manufacturers reserve specific tasks or software for their own agents, and warranty terms may add conditions. Check the instructions and any warranty for your model. Where a manufacturer restriction applies to work we are asked to do, we tell you.

What should we do if a chair injures a patient or a member of staff?

Make the equipment safe and take it out of use, record what happened, and report it. Adverse incidents involving medical devices are reported to the MHRA through the Yellow Card scheme, and some incidents must also be notified to the CQC. We can provide a technical report on the equipment to support your investigation; the decision to report, and the report itself, are the practice's.

Other topics

Not sure what records you should have?

The Practice Engineering Survey establishes what exists and what is missing, without claiming to be an audit.

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