The new article highlights the aspects related to the classification of medical devices the UK authority intends to improve by the virtue of amending the existing regulatory framework.
The Medicines and Healthcare products Regulatory Agency (MHRA), a UK authority in the sphere of healthcare products, has published its roadmap for the change program related to software and AI-based products subject to regulation as medical devices. The document provides an overview of the approach the authority intends to apply when improving the existing regulatory framework and also outlines the key points the authority pays the most attention to. At the same time, the document itself is non-binding in its legal nature, nor is intended to introduce new rules or impose new obligations, but rather to provide general guidance on further regulatory developments so the medical device manufacturers (software developers) and other parties involved could consider them when planning future activities.
The scope of the document covers, inter alia, the aspects related to the classification of software products, including the ones based on Artificial Intelligence (AI) technologies, regulated as medical devices. In this respect, the authority acknowledges that the existing legal framework represented by the Medical Device Regulations 2002 is not efficient enough in regulating the matters related to the classification of software products based on the risks associated thereto. Thus, the authority sees the following objectives to be achieved as a result of upcoming regulatory improvement:
- Ensure classification rules closely follow the risk that specific SaMD poses to the patient and public safety where this is known;
- Ensure classification rules impose safety and performance requirements proportionate to the risk which SaMD application pose; and
- Ensure that classification rules provide sufficient flexibility so that the risk profile of novel devices can be addressed without needlessly restricting innovation.
The document further describes the steps the authority intends to take in order to achieve the above goals.
Classification Rules Reform
First of all, the authority intends to introduce a classification rules reform by amending the secondary legislation. The new regulations are expected to be in line with the general principles suggested by the Possible Framework for Risk Categorisation proposed by the International Medical Device Regulators Forum (IMDRF), a voluntary association of national regulating authorities working together for further improvement of regulations related to medical devices. Thus, the MHRA conducts a rigorous analysis of the international approach to the classification of software-based medical devices in order to establish the way it could be considered when making changes to the respective national regulations.
The authority further acknowledges that sometimes medical device manufacturers working on products intended to address critical unmet clinical needs could have difficulties with collecting sufficient clinical evidence necessary to substantiate an application for marketing approval as required under the general rules. In order to expand the availability of innovative medical devices addressing unmet needs while ensuring their safety and public health protection in general, the authority intends to apply an “airlock process”, allowing such products to be used in the intended use environment so then the necessary clinical evidence could be generated. At the same time, in the course of such use, medical devices will be closely monitored to ensure any and all safety- or peraformance-related issues are duly identified and addressed.
Should the authority decide to implement the above approach, it will conduct public consultations to collect feedback from the parties involved with respect to the way efficient monitoring could be conducted with respect to risks associated with software-based medical devices. It is further stated that such a regulatory sandbox will be introduced:
- According to set of criteria applied by MHRA and/or Approved Bodies;
- Allow for heightened monitoring of the device;
- Have a clear set of entry and exit criteria.
Once the regulatory approach described hereabove will be implemented, it will be easier for medical device manufacturers to enter the country’s market with products based on innovative technologies since they will be able to collect proper evidence providing important information about the actual performance of their products.
Guidelines and Clarifications
In order to assist the parties involved in operations with software-based medical devices, the authority also intends to issue additional guidance documents providing clarifications with respect to the amendments to the regulatory framework and the way they should be interpreted. These guidelines will describe in detail the aspects that are not addressed properly in secondary legislation, and also contain examples illustrating the approach to be applied.
In summary, the present MHRA roadmap document outlines the key issues the authority has identified with respect to the classification rules for software-based medical devices (including the ones utilizing Artificial Intelligence technology). The document also describes the particular way the authority intends to address these issues, including the steps the authority will take. According to the document, the authority will pay most attention to the classification rules which are not efficient enough in addressing the risks associated with software-based medical devices. Apart from that, the authority is currently considering an option to introduce a regulatory sandbox to allow the use of medical devices when additional clinical evidence is still to be collected, provided such use is properly supervised and all the measures are taken to ensure the safety of patients.
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