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General Safety Requirements

The following requirements from Schedule 1, Part 1 of the Medical Devices Regulations apply to all medical devices regardless of class.

1. Risk minimisation​

A medical device must be designed, manufactured, and packaged in a way that, when used under the conditions and for the purposes intended, and having regard to the technical knowledge, experience, education, or training of its intended users, the risks associated with its use are acceptable having regard to the benefits of the device.

In practice, this means:

  • Identify all foreseeable hazards associated with the device
  • Estimate and evaluate the associated risks
  • Eliminate or reduce risks through design
  • Provide protective measures where risks cannot be eliminated
  • Provide information (warnings, precautions) to users for residual risks

Key standard: ISO 14971 — Risk Management for Medical Devices

2. Benefit-risk balance​

The benefits of the device to the patient and user must outweigh any residual risks. The benefit-risk analysis must consider:

  • The severity and frequency of harm
  • The clinical benefit for the intended patient population
  • The availability of alternatives

3. Performance over the device's lifetime​

The device must maintain its performance characteristics over the expected service life of the device when:

  • Used under normal conditions of use
  • Stored and transported in accordance with labelling
  • Subjected to reasonably foreseeable maintenance and repair

4. Compatibility and interaction​

A device must be designed and manufactured to not compromise the safety or health of patients, users, or third parties when used with other devices, accessories, or substances it is intended to be used with.

5. Devices that deliver energy or substances​

For devices that deliver energy (e.g., electrical stimulation, radiation) or substances (e.g., infusion pumps, drug delivery devices), additional requirements apply:

  • Output must be adequately controllable and adjustable
  • The device must have sufficient accuracy
  • Warning and alarm systems must be provided where appropriate

6. Devices with a measuring function​

Devices designed to have a measuring function must:

  • Have sufficient accuracy for the intended purpose
  • Express measurements in legally recognised units where applicable

7. Protection against radiation​

Devices that intentionally emit ionising or non-ionising radiation must:

  • Limit emitted radiation to the minimum necessary for the intended purpose
  • Provide protection against unintended radiation exposure

Legislative source: Medical Devices Regulations, SOR/98-282, Schedule 1, Part 1