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EP 1–6 General Principles

Overview​

Essential Principles 1 to 6 are the general principles that apply to all medical devices regardless of type or classification. They establish the overarching requirements for device safety, performance, fitness for purpose, durability, packaging integrity, and protection of users and third parties. Every medical device technical file must address all six of these principles.

EP 1 — Use of Medical Devices Not to Compromise Health and Safety​

What it requires: Medical devices must be designed and manufactured so that when used as intended, they do not compromise the safety or health of patients, users, or third parties. Any risks associated with the device must be acceptable when weighed against the benefits and must be compatible with a high level of protection of health and safety.

In practice: This is the foundational safety principle. It requires manufacturers to conduct a thorough benefit-risk analysis as part of their design process. Residual risks that cannot be eliminated must be justified against the clinical benefits. The analysis must be documented and maintained throughout the device lifecycle.

Relevant standard: ISO 14971 — Risk management for medical devices

EP 2 — Design and Construction to Conform with Safety Principles​

What it requires: The solutions adopted for design and construction must conform with safety principles, having regard to the generally acknowledged state of the art. Manufacturers must follow a specific hierarchy when addressing risks:

  1. First — eliminate or reduce risks by inherently safe design
  2. Second — provide adequate protective measures (including alarms) for risks that cannot be eliminated
  3. Third — inform users of residual risks through labelling and instructions for use

In practice: This establishes the risk control hierarchy. Designing out a hazard is always preferable to warning about it. This principle underpins the entire design control process and must be evidenced in risk management documentation.

Relevant standards: ISO 14971, IEC 60601 series (active devices)

EP 3 — Medical Devices to be Fit for Intended Purpose​

What it requires: Medical devices must perform as specified by the manufacturer. The device must achieve its intended performance under normal conditions of use, and its design and production must ensure it is suitable for the purposes set out in the definition of a medical device (as described in Section 41BD of the Act).

In practice: Manufacturers must define the intended purpose clearly and comprehensively, and then demonstrate through testing, clinical evidence, and design validation that the device actually achieves that purpose. Performance claims in labelling must be substantiated. This principle connects directly to the clinical evidence requirements of EP 14.

EP 4 — Long-Term Safety​

What it requires: The characteristics and performance of a device for safety and performance must be maintained throughout the period of safe use indicated by the manufacturer. This applies provided the device is used within its specified period, not subjected to stresses beyond normal use, and regularly maintained and calibrated according to manufacturer instructions.

In practice: Manufacturers must define a service life or expiry period based on testing (stability, ageing, fatigue testing). For reusable devices, the number of reuse cycles must be validated. For implantable devices, the long-term biocompatibility of materials must be demonstrated.

Relevant standards: ISO 11135 (sterilisation), relevant stability testing standards, ISO 10993 series (biocompatibility)

EP 5 — Medical Devices Not to be Adversely Affected by Transport or Storage​

What it requires: Medical devices must be designed and manufactured so that they are not adversely affected by transport and storage conditions that might reasonably be anticipated, having regard to the instructions provided.

In practice: Manufacturers must establish and validate storage and transport conditions (temperature, humidity, pressure, shock, vibration) and ensure that the device performs as specified after being subjected to those conditions. Packaging must be validated for its protective function. Shelf-life claims must be supported by stability data.

Relevant standards: ASTM D4169, IEC 60068 series, ISO 11607 (sterile barrier)

EP 6 — Medical Devices Not to be Harmful to Persons Associated with Their Use​

What it requires: Any side effects from the use of the device must constitute acceptable risks when weighed against the intended performance of the device. This applies to patients, users, and any other persons who may come into contact with the device.

In practice: This principle addresses indirect and unintended harms — for example, electromagnetic interference affecting other devices, noise or vibration affecting users, or chemical emissions affecting the environment. It requires manufacturers to consider the full context of device use and address any foreseeable hazards beyond those directly related to the device's primary function.

Official Sources​