The new article highlights the key points related to the regulatory requirements associated with changes to the materials used in medical devices. Also, it outlines the scope of information to be included in the medical device change form to be submitted by the manufacturer.
Table of Contents
The Saudi Food and Drug Authority (SFDA), a country’s regulatory agency in healthcare products, has published a guidance document dedicated to the changes to medical device marketing approval changes. The document explains the approach to be applied to distinguish significant and non-significant changes based on their nature and risks associated thereto. It is also important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be taken into consideration by medical device manufacturers in order to ensure compliance thereto. Moreover, the authority reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document describes different types of changes to medical devices already placed on the market and the approach to be applied when implementing them.
Changes to Materials
With respect to changes to the materials used for a medical device, the authority mentions that when implementing such changes, the manufacturer should also take into consideration other types of change associated thereto – for instance, changes to the design or labeling. All such changes should be subject to a rigorous assessment and implementation in accordance with the applicable regulatory requirements.
Furthermore, medical device manufacturers are responsible for documenting all the changes to materials used (e.g., changes to the material type, formulation, or chemical composition). The scope of the respective assessment to be conducted should cover the aspects related to biocompatibility and physical properties. When assessing the impact the proposed changes could have, the manufacturer should pay attention to the materials themselves, as well as processing and manufacturing methods, the sterilization process applied, and also residuals that potentially can remain upon completion of the process. According to the guidance, any process or method changes, including material supply changes (changes made by material supplies or changes from one supplier to another) should be evaluated for their impact on safety and effectiveness.
Apart from the abovementioned aspects, a medical device manufacturer intended to make changes to the materials should also take into consideration whether the same material in any of its states is used in any other medical device placed on the market. As explained by the SFDA, references to the use of the same materials in another medical device could be provided to demonstrate compliance with the applicable safety and performance requirements – for instance, to demonstrate biocompatibility – provided the material in question has the same formulation or chemical composition and is subject to the same processing, including sterilization (i.e., the comparison should be between materials as they are applied in the final finished device, not between raw materials). The authority also mentions that sometimes the size and geometry could also impact the materials’ properties. Consequently, these factors should also be taken into consideration. According to the document, any change in chemical composition, manufacturing process, physical configuration (e.g., size, geometry, surface properties), or intended use of the device should be evaluated with respect to possible changes in biocompatibility and the need for additional biocompatibility assessment. Should the medical device, upon implementation of the changes proposed, appear to have a higher risk category in terms of contact due to the different nature of such contact or its duration, an additional assessment will be required to ensure the proper performance of the device and the safety of patients.
If the materials to be used are currently used in other devices placed on the market, the scope of consideration should cover the aspects related to the way such a change could potentially affect the actual performance of the product due to the possible changes to its mechanical properties. Moreover, it is also important to assess whether the materials used could be affected by any of the processes the device will undergo throughout its lifecycle (e.g., sterilization, cleaning, or disinfection).
Changes to Safety and/or Performance Characteristics
The guidance also describes the approach to be applied with respect to changes to the safety and/or performance characteristics of a medical device allowed for marketing and use. In particular, it is stated that any changes resulting in a significant change to the product’s safety and/or performance should be considered significant and treated accordingly.
Medical Device Change Form
Apart from describing the approach to be applied with respect to different types of changes, the authority also provides an example of a medical device change form to be submitted by a party responsible for a medical device with respect to the changes to be implemented. The said form should contain all the important information regarding the proposed changes so the authority can assess their impact on the safety and performance of the device. According to the guidance, such a form should contain the following elements:
- Manufacturer information (including its name, address, and authorization number);
- Medical device information (including its name, model number, and listing number, as well as an indication of a risk class under the applicable risk-based classification);
- Nature of the change (including the indication of a specific aspect affected by the change, as well as the details on the risk management and a detailed description of the changes proposed);
- Change categorization (indication of whether the change(s) in question are significant or non-significant, based on the initial evaluation conducted by the medical device manufacturer);
- Declarations whereby the manufacturer explicitly confirms that all the documents related to the changes have been submitted to the authority and that the information contained therein is true and correct.
The form should be dated and signed by an authorized signatory representing the manufacturer.
In summary, the present SFDA guidance describes in detail the approach to be applied with respect to changes to materials used for a medical device. The document also provides an example of a form to be submitted to the authority when implementing the changes.
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