Principle 1 - Use of medical devices not to compromise health and safety

The legislated requirements

Devices must be designed and produced so they won't compromise the safety and health of patients or other people. Every device comes with potential benefits as well as risks. Principle 1 states that the benefits to the patient must outweigh the risks, while still ensuring that health and safety can be protected to a high level.

All manufacturers must comply with this Principle.

The legislation says:

Meeting Principle 1 - Guidance for manufacturers

You must consider the Principles when designing, developing, manufacturing, and supplying your device. You must consider risks from normal use and known and foreseeable hazards and unwanted effects that could arise throughout the expected lifetime of the device. Undesirable hazards and risks must be removed and minimised as far as possible. All hazards and risks must be acceptable when weighed against the benefits of the intended performance (see Principle 6).

Some aspects for you to consider include:

• design, materials and construction of
• intended purpose of
• who will use
• how will people use
• the intended treatment setting of

the device.

You should apply and maintain a risk-management process. This includes ongoing risk analyses that consider potential and known hazards that could occur during:

• design
• production,
• use, and
• decommissioning

throughout the expected lifetime of the device. You should examine and test risk-mitigation strategies to show that any measures used to reduce identified risks are effective.

You should apply a risk-management process before product development begins, as this will generate safety requirements for the design, manufacturing, and operation specifications. The design specification should include design transfer (to production) and production requirements (for example, specifications, tolerances, testing).

You must record well-reasoned evidence-based analyses of:

• known and foreseeable hazards from using the device, and
• benefits from using the device for the patient and user of the medical device.

These analyses must compare the risks and benefits from using the device and recognize the importance of safety for patients, users and other persons.

You must generate evidence that you meet Principle 1. At minimum, you should:

• identify and record the intended user. Explain in the Instructions for Use (IFU) what technical knowledge, experience, education and training is needed to use the device safely and as intended (if applicable). See also Principle 9, Principle 12.1 and Principle 13.
• identify and record the intended environment for use, including any required risk controls (for example, electrical or radiation safety)
• record evidence of design (including, where possible, designing out risks)
• record evidence of verification and validation (including testing)
• apply a rigorous, well-reasoned and documented risk management process
• review relevant published literature
• review your, and your customers', experience with the device
• assess and record compliance of the device and its packaging with specifications and relevant technical standards (for example, IEC 60601)
• review and document the labelling, IFU and patient information provided with the device. Include guidance to help the intended user decide whether the device is working correctly or not. Include calibration, maintenance, and servicing information where applicable
• perform studies to design and test for human factors (including useability) with a representative sample of intended users, where applicable
• validate information provided with the device (for example, labels and IFU) with a representative sample of intended users
• review and record final release procedures
• generate and critically evaluate the clinical evidence (see Principle 14). This could include a robust search of international and national studies.
• review the latest research on effective methods for protecting health and safety to a high level.