The new article highlights the aspects related to the general essential requirements, as well as the ones related to the design of medical devices to be followed in order for the latter to be allowed for marketing and use in the United Kingdom.
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published a guidance document dedicated to stand-alone software products subject to regulation as medical devices (the scope of the guidance also covers the products regulated as in vitro diagnostic medical devices / IVDs). The document is intended to provide an overview of the existing regulatory framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers (software developers) and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The document provides, inter alia, additional information about essential requirements software-based medical devices should meet in order to be allowed for marketing and use in the country.
First, the guidance provides an overview of the general regulatory requirements that apply to all products regulated as medical devices. In this respect, the authority states that the devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the technical condition or the safety of the patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended 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.
In this respect, the parties responsible for medical devices should:
- Take all the necessary measures to mitigate to the maximum extent possible potential risks associated with the ergonomic features of their products, as well as the intended use environment, ensuring the safety of patients;
- Take into consideration the expected level of technical knowledge and experience of persons supposed to use the device.
Furthermore, any and all solutions employed by medical device manufacturers in terms of design and construction should comply with the applicable safety principles. When deciding on specific solutions to be used, parties responsible for medical devices should apply the below principles in the respective order:
- Eliminate or reduce risks as far as possible (inherently safe design and construction);
- Where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated;
- Inform users of the residual risks due to any protection measures’ shortcomings.
In order to be allowed for marketing and use in the country, a medical device in question should actually perform as intended by the manufacturer when used for its intended purpose. Moreover, even when being impacted by the factors that are usual for the intended use environment, the device should continuously comply with the applicable safety- and performance-related requirements. The device’s packaging should be designed to ensure the device will not be affected when being transported and stored in accordance with the instructions communicated by its manufacturer.
The authority additionally emphasizes that any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.
In order to demonstrate compliance with the abovementioned requirements, a clinical evaluation should be conducted, and its results should be presented by a medical device manufacturer applying for marketing approval.
Design and Construction Essential Requirements
The document further describes in detail the aspects related to the design and construction of medical devices from the essential requirements perspective. In particular, the guidance outlines the relevant essential requirements and states that it will be a medical device manufacturer’s responsibility to determine the ones that should apply based on the nature of the device in question, its functions and features, as well as other relevant matters. For instance, these requirements include the following:
- If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system, must be safe and not impair the devices’ specified performances. Any restrictions on use must be indicated on the label or in the instructions for use.
- Devices incorporating electronic programmable systems must be designed to ensure these systems’ repeatability, reliability, and performance according to the intended use. In the event of a single fault condition (in the system), appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.
- Each device must be accompanied by the information needed to use it safely and properly, taking into account the training and knowledge of potential users and identifying the manufacturer.
Additional requirements should also be considered with respect to the labeling used. Under the general rule, labeling should contain sufficient information for end-users to be able to use the product in a safe and efficient way, with such information being provided in a way ensuring it will be interpreted correctly by end-users based on their level of knowledge and experience in the field of medical devices. When it takes to software-based products, the authority additionally emphasizes the following aspects:
- Should the device be intended to be used together with another medical device, the instructions provided by the manufacturer should describe this in sufficient detail;
- The manufacturer should also duly communicate the information about the way proper installation of the device could be verified.
In summary, the present MHRA guidance provides an overview of the essential requirements to be applied with respect to software-based medical devices. The document pays special attention to the design-specific requirements and also provides additional clarifications regarding the labeling and information it should contain.
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