The article provides an overview of the regulatory requirements for specific Change Notification applications.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to Change Notification applications arising from the changes related to the Medical Devices Regulation 2017/745 (MDR) and In Vitro, Diagnostic devices Regulation 2017/746 IVD) concerning registered medical devices. The document complements the guidance dedicated to the general rules for Change Notifications. The guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are 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 such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
First of all, the authority mentions that the European Union (EU) is one of HSA’s five reference regulatory agencies commonly referenced in abridged evaluation routes for medical device registration. The authority acknowledges the impact new EU Regulations cause on the applicable regulatory requirements, resulting in changes to medical devices, as well as their labeling and instructions for use (IFU). The present guidance describes in detail the approach HSA applies concerning such changes and change notification applications associated thereto. As explained by the authority, the document remains effective until the end of 2025. For the changes that are not directly related to the said EU Regulations, the authority refers to the general Guidance on Change Notification for Registered Medical Devices.
The document further highlights the key points related to the changes to medical devices to be implemented in response to the new EU regulatory framework. In particular, the scope of the guidance covers the following changes:
- Changes to label and IFU with no new information related to safety and performance (GMD and IVD);
- Change to label and IFU related to material “-Free” claims (GMD);
- Changes to IFU related to clarification of existing content and addition of safety information (GMD and IVD);
- Changes to IFU (IVD) related to clarification of performance data.
The document further describes the above mentioned changes in detail and highlights the key points associated thereto, and also outlines the eligibility criteria to be applied when determining the admissibility of such applications. For instance, the changes to the instructions for use related to clarification of performance data for IVD products should meet the following criteria:
- Changes due to EU IVDR updates,
- No change to a method of use,
- No change to device design, specifications, or performance,
- No additional preclinical/clinical validation is required to support safety and effectiveness.
Submission of Changes – Multiple Devices
Apart from the above, the document also describes the approach to be applied to the submission of changes affecting multiple medical devices allowed for marketing and use in the country. According to the guidance, the same change within different registration dossiers could be subject to review under a single application provided that:
- Changes are in the context of EU MDR/IVDR updates, and meet the criteria for submission as described [in the guidance];
- Device listings are of the same risk class;
- Change involves identical symbols and/or identical statements/paragraphs.
The authority further mentions that the number of identical changes to be included in one Change Notification application is not limited. The entity responsible for a medical device should also indicate in the application that the changes are to be implemented in connection with the new EU Regulations.
In case the changes are to be made to different models of the same medical device registered under the single entry, the details on all such changes should be included in one application. Such an application should include, inter alia, a table describing how the changes correspond to specific medical device models. Apart from this, an entity responsible for a medical device may submit a comparison table illustrating changes to the instructions for use. According to the guidance, such a table should include, inter alia, the following details: IFU page number, specific IFU section(s), and details of changes made to the content (e.g., describe changes made to wording, images, and diagrams). The authority additionally emphasizes that such an approach could be applied only to the instructions for use.
To bundle changes together, the authority refers to the general grouping rules and guidelines explained in the respective guidance document dedicated to change notification applications. Under the general rules, all the related changes should be submitted within 6 months from the date they were implemented for the first time concerning a device placed at any market. Recommendations provided in the said guidance would also apply in case of any other changes falling outside the scope of the present guidance.
The guidance also provides several examples illustrating the way the approach described therein should be applied in specific cases. At the same time, it is important to mention that the examples are provided for reference purposes only, while each situation should be assessed on a case-by-case basis.
In summary, the present HSA guidance describes the regulatory status of changes to registered medical devices implemented in response to the corresponding changes to the EU regulatory framework. The document provides additional clarifications concerning Change Notification applications related to such changes, outlines the eligibility criteria, and also highlights the key points associated thereto.
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