The new article addresses specific aspects regarding the Essential Principles medical devices should comply with to be allowed for marketing and use in Singapore. In particular, the article describes in detail the general requirements to be followed, and also the principles related to clinical investigations.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the Essential Principles for Safety and Performance of medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and the authority reserves the right to amend the guidance, should it be necessary to reflect the respective changes to the underlying legislation.
General Requirements
Under the general rule, medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by the technical knowledge, experience, education, or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. As it is further stated, an entity responsible for a medical device should develop and implement an efficient risk management system to ensure that all the products manufactured are compliant with the applicable regulatory requirements in terms of safety, quality, and effectiveness. The authority additionally emphasizes that risk management is an ongoing process that should cover all the stages of the product’s lifecycle. Moreover, the risk management system should be subject to regular review and updates based on the new information which becomes available to the manufacturer. The main obligations of the latter are the following:
- To develop and implement a written risk management plan regarding each of the devices manufactured;
- Continuously analyze the information about the risks associated with the product;
- Implement measures intended to mitigate the risks associated with the use and potential misuse of the device;
- Evaluate all the information regarding the device, its performance, and risks associated thereto;
- Implement control measures based on the risks identified and information evaluated.
As was mentioned before, the manufacturer is responsible for implementing special measures intended to mitigate the risks associated with the product arising when it is used for the intended purpose, or in case of reasonably foreseeable misuse. According to the guidance, the manufacturer should evaluate the risks associated with the device to ensure they are acceptable. In this regard, the following process should be followed:
- Identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;
- Eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
- Reduce as low as is reasonably practicable the remaining risks by taking adequate protection measures, including alarms;
- Inform users of any residual risks;
- Provide information for safety (warnings, precautions, contradictions, indications) and, where appropriate, training to users.
Thus, to ensure the overall safety of the medical devices it is responsible for, the manufacturer should:
- Reduce to the maximum extent possible the risks associated with the use and misuse of the product in the environment in which it is intended to be used;
- When implementing the risk mitigation measures, consider the expected level of knowledge of potential users, their education, experience, and also physical conditions (if applicable).
It is also important to mention that the device should be designed and manufactured in a way ensuring that the external factors the device is subject to when used for the intended purpose in the intended use environment are not impacting adversely the safety and effectiveness of the device. Moreover, the packaging of the device should ensure its continued safety and effectiveness during transportation and throughout the whole period of shelf life of the device, ensuring protection against various external factors, such as humidity or fluctuation of temperature.
The document also mentions that medical devices should have the stability necessary to maintain essential performance conditions in a period and conditions previously established during the shelf-life, during the time of use after being opened (for in vitro diagnostic devices, including after being installed in the instrument), and during transportation or dispatch when under conditions other than storage conditions.
As was mentioned before, the manufacturer is responsible for identifying potential hazards associated with the device, arising when the device is used. In this respect, the manufacturer should also consider potential misuse of the device in a reasonably foreseeable way. All the risks should be duly mitigated to an acceptable level, considering the general technology development and solutions available.
Clinical Evaluation
The scope of the Essential Principles also covers the aspects associated with the clinical evaluation of medical devices to be performed to collect additional information regarding the actual safety and effectiveness of a medical device in the intended use environment. Under the general rule, every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the essential principles. For this purpose, the appropriate clinical study should be designed and conducted. The said evaluation is intended to collect additional data to be used to evaluate the benefit-risk profile of a medical device. The final determination could be in one of the following forms:
- Clinical investigation reports;
- Published scientific literature reviews;
- Clinical experience.
The authority also mentions that when conducting clinical investigations the responsible party should strictly adhere to the ethical principles based on the Declaration of Helsinki to ensure the protection of rights and safety of study participants – the aforementioned values should prevail over the scientific purposes. As it is stated in the document, the said principles should be followed at all stages of the clinical investigation process.
In summary, the present HSA guidance provides an overview of the general requirements set forth by the Essential Principles for Safety and Performance of medical devices. The document also highlights the aspects related to the clinical investigations and the way they should be conducted to ensure compliance with the respective principles and requirements.
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