The new article describes in detail the aspects related to changes to the software used in medical devices, as well as materials and labeling.
Table of Contents
The Tanzania Medicines and Medical Devices Authority (TMDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the submission of applications for changes to medical devices already placed on the market and allowed for marketing and use in the country. The document is intended to provide additional clarifications regarding the regulatory requirements to be applied, 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 are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the corresponding changes to the underlying legislation.
The scope of the guidance covers both general and in vitro diagnostic (IVD) medical devices. In particular, the guidance addresses the aspects related to the decision trees to be applied when determining the regulatory nature of the changes and the specific pathway to be followed.
Changes to Software
The decision tree E describes the approach to be applied concerning the changes to the software. The authority mentions that most of such changes would require an application to be submitted by the manufacturer. As further explained by the TMDA, the software changes considered significant include, inter alia, the following ones:
- A software change, which impacts the control of the device, may alter the diagnosis or therapy delivered to the patient;
- A change in the software that modifies an algorithm impact the diagnosis or therapy delivered;
- A software change that impacts the way data is read or interpreted by the user, such that the treatment or diagnosis of the patient may be altered when compared to the previous version of the software;
- A software change that replaces previously required user input a closed-loop decision;
- Addition of a new feature to the software that may change the diagnosis or therapy delivered to the patient.
According to the document, significant changes also include the ones related to the alarm function if they are expected to affect the use of the device, as well as the changes to the operating system the software is based on.
The authority also mentions that approval will be required in case of changes intended to correct a software-related error that may adversely impact the safety of patients and expose them to additional risks. If the changes to the software are to be introduced in the course of safety corrective and preventive actions taken by the manufacturer, the latter is encouraged to contact the authority to discuss the changes in question and determine the regulatory approach to be applied based on the nature of such changes and their expected impact on the safety and performance of the medical device. At the same time, if the correction is related to minor aspects and would not impact the overall safety and effectiveness of the product, they won’t be considered as significant. For instance, non-significant changes would include:
- A software change that only introduces non-therapeutic and/or non-diagnostic features such as printing, faxing, improved image clarity, reporting format, or additional language support;
- A software change that only modifies the appearance of the user interface with negligible risk of impacting the diagnosis or therapy delivered to the patient;
- A software change that disables a feature that does not interact with other features.
Hence, the regulatory approach to be applied concerning changes to software depends on the impact such changes are expected to have.
Changes to Materials
Decisions trees F and G describe the changes to materials used for general and IVD medical devices respectively. The authority pays special attention to such changes as this may result in subsequent changes to the manufacturing process in general, as well as device performance specifications. Concerning the criteria to be applied when determining the significance of such changes, the authority emphasizes the following aspects:
- All changes to the sourcing or processing of materials of human or animal origin are considered significant and result in an application for change approval;
- Changes within a single generic material type or changes in the formulation can affect the chemistry, metallurgy, or other property, such as stability, of the device.
According to the guidance, special attention should be paid to the case of surgically invasive devices, especially the ones intended to be absorbed by the patient’s body. Hence, in case of changes to patient-contacting materials, the respective application is to be submitted. In case the changes to materials result in corresponding changes to the design specifications, the recommendations related to decision tree C should be followed.
However, in case the changes are related only to the particular supplier, while the materials supplied still meet to a letter the applicable specifications, such changes would not be considered significant.
Concerning IVD products, the authority mentions that changes to materials that necessitate the testing of additional clinical samples to determine the performance characteristics of the IVDD would be considered a significant change unless the additional clinical testing only confirms that the altered IVDD still conforms to the approved performance specifications and no labeling changes are necessary.
Changes to Labeling
As it was mentioned before, the scope of the guidance also covers the changes related to medical device labeling. Usually, such changes result from the other changes – e.g., the changes to performance specifications and materials. According to the document, each change to the medical device labeling should be considered separately as described in the decision tree H.
For the changes to labeling, the authority highlights the following key points:
- Changes to the intended use or indications for use will require a new application unless the changes are within an approved set of indications;
- Changes within an approved set of indications should be submitted at the renewal or as change notification (however, if a limitation to the indications for use is introduced as a result of concerns associated with the safe and effective use of the device, a contradiction must be added; and this will be considered a significant change).
In summary, the present guidance provides an overview of the regulatory requirements to be applied concerning various changes to medical devices. The authority explains the approach to be applied when determining the regulatory nature of changes and the particular pathway to be followed.
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