The Importance of Understanding Side Effects, Adverse Effects, and Residual Risks in Medical Devices

EU MDR 2017/745 requires that the Instructions for Use (IFU) include information about any residual risks and undesirable side effects. This means that no type of residual risk or undesirable side effect related to the device can be excluded from disclosure. The Summary of Safety and Clinical Performance (SSCP) also should contain information on at least the same residual risks and undesirable side effects as included in the IFU.

Understanding side effects, adverse effects, and residual risks in medical devices is of utmost importance for both healthcare professionals and patients. In the field of healthcare, there are certain terms used to describe potential risks associated with a specific medical device or treatment. As medical device manufacturers, it is important to navigate the challenge of effectively disclosing and communicating these to the end users. Ensuring transparency and providing clear information can help end-users make informed decisions about their healthcare options.

Discover how this article simplifies the process of differentiating between these terms.

Side effects are unintended and often undesirable effects that occur when using medical devices as a result of their normal use. E.g.: The most common sign of hernia mesh complications is pain and discomfort, which may be accompanied by bruising or swelling. Healthcare professionals must be aware of these side effects so that they can inform patients about them and manage any potential complications effectively.

As per MDCG 2023-3, an ‘undesirable side-effect’ under the EU MDR should be understood as any unintended and unwanted medical manifestation in the human body, as a consequence of the normal use of a device. Undesirable side effects are not the result of a malfunction, deterioration in the device’s characteristics or performance, or inadequacy in the information supplied by the manufacturer. An unsuccessful treatment (or treatment failure) should not be considered an undesirable side effect.

Undesirable side effects can be expected or unexpected and are considered incidents under the MDR (Article 2(64)).

Expected undesirable side-effects must be clearly documented in the product information, and quantified in the manufacturer’s technical documentation. They must also be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use (Section 8 of Annex I MDR).

Unexpected undesirable side effects are not considered in the manufacturer’s risk analysis, quantified in the manufacturer’s technical documentation or documented in the product information. If it occurs, it must be handled like all incidents and must be reported in accordance with the requirements of EU MDR.

Adverse effects/reactions, on the other hand, are more severe than side effects and can pose significant risks to patient health. Unlike side effects, adverse effects are directly related to the intended purpose of the medical device or treatment. It is generally harmful, and undesirable and it may occur due to various factors such as individual patient characteristics or incorrect usage of the device. This must also be handled like all incidents and must be reported in accordance with the requirements of EU MDR.

Residual risks refer to the ongoing risks associated with using a medical device even after all risk control measures have been implemented. Despite thorough testing and regulatory approval processes, there may still be certain risks that cannot be eliminated. Understanding these residual risks allow healthcare professionals to make informed decisions about choosing appropriate treatments for their patients. As per ISO/TR 24971, residual risks can relate to the possible occurrence of side effects or after-effects. The disclosure of residual risks can be useful for the end users to prepare for possible side effects or harms that can occur during or after the use of medical devices. E.g.: Mechanical ventilation to assist or replace spontaneous breathing can lead to complications such as airway injury, alveolar damage or pneumothorax.

By understanding expected side effects, and residual risks associated with medical devices from the accompanying documents provided by the manufacturers, healthcare professionals can provide accurate information to patients regarding potential outcomes and help them make well-informed decisions about their healthcare choices. Additionally, this knowledge enables healthcare providers to develop suitable risk mitigation strategies while ensuring patient safety remains paramount. 

In conclusion, comprehending side effects, adverse effects, and residual risks in medical devices is crucial to facilitate effective communication between manufacturers, healthcare providers and patients while promoting patient safety throughout the treatment process.

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