The new article describes in detail the aspects related to the existing premarket requirements and the improvement they require.
Table of Contents
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, including medical devices, has published a guidance document describing the approach it intends to apply with respect to the further development of the regulatory framework for products that are classified as software and artificial intelligence (AI) as a medical device. The document is dedicated to the steps the authority is going to take in the context of further improvement of the applicable regulations to make sure the known gaps and issues are properly addressed.
The scope of the document covers, inter alia, the aspects related to premarket requirements. First of all, the authority acknowledges the need for clearer premarket requirements in order to facilitate the process associated with placing new products on the market while ensuring their proper performance and the safety of patients.
In this respect, the authority outlines the main objectives, namely:
- Ensure SaMD is supported by adequate data on safety, effectiveness, and quality prior to being placed on the market, ensuring these requirements are proportionate to the risk the device presents;
- Ensure that premarket requirements, especially clinical evince and clinical investigation requirements, are clear in how they apply to and are appropriate for SaMD;
- Ensure that any premarket submission includes all necessary information to support the safe use of SaMD.
In order to make sure the above goals are achieved, certain amendments to secondary legislation will be required. The document further provides an overview of such changes, accompanied by additional clarifications and justification.
First of all, the authority pays attention to the changes needed with respect to essential requirements for software, since the ones set forth in the Medical Devices Directive should be aligned with the international best practice. According to the guidance, an update is needed to ensure they provide robust assurance that software meets its intended purpose and is safe for patients and users.
As it is mentioned in the guidance, the authority has already conducted a rigorous review of the existing regulatory requirements and determined the aspects that require further improvement. In particular, the changes suggested are intended to accommodate better the specifics of software-based products, and also to improve the overall ease of use of the regulations in general. Based on the said review, the authority has developed and published the appropriate consultation paper.
The document also pays attention to the aspects related to best practices. In this respect, it is stated that the best practice for SaMD development requires the best of both software development and medical device development. The authority works closely with the BSI, which is the country’s national standards body, reviewing the current practices described in the existing standards in order to identify the aspects that require further improvement. It is also important to mention that the new MHRA guidance will not replace IEC 62304 or other key standards utilized by manufacturers of SaMD, but it will serve to highlight areas where current best practice may not meet regulatory requirements or regulatory definitions of the “state of the art”.
The document also addresses the aspects related to the regulatory status of retrospective non-interventional performance studies involving SaMD. In particular, the authority mentions that the existing regulatory framework does not clearly specify whether they are subject to notification or registration requirements. In order to resolve this, the authority intends to update existing guidance to indicate when these studies qualify as clinical investigations or an IVD undergoing performance evaluations, thereby clarifying what needs to be notified or registered with [MHRA].
Joint Regulatory Guidance
According to the document, MHRA also intends to cooperate closely with the Health Research Authority (HRA) in order to develop joint regulatory guidance addressing:
- The main points of consideration from both the perspective of governance of research as well as medical device development;
- The major processes that need to be undertaken and the key points at which these processes begin;
- The key pieces of existing guidance to support all of the above.
The aforementioned joint guidance will provide additional clarifications regarding the connection between medical devices and the research governance process.
The authority also mentions that a human-centred approach will be applied in terms of SaMD design, being an approach to interactive systems that aims to make systems usable and useful by focusing on the users, their needs and requirements, and by applying human factors/ergonomics, and usability knowledge and techniques. The MHRA acknowledges the existing risk of the output provided by the software being misinterpreted by users, affecting the safety and overall effectiveness of the software. In order to address the related issues, the authority intends to develop a guidance document emphasising the importance of taking into consideration the human factors, usability, ergonomics and related matters in the course of SaMD development.
The authority mentions that the existing nomenclature applied with respect to software-based medical devices is sometimes too broad and is not precise enough. In order to address the related issues, the authority intends to take further steps to improve the current nomenclature, including collaboration with the Global Medical Device Nomenclature (GMDN) Agency to align the regulatory approach applied.
In summary, the present MHRA guidance describes the approach the authority intends to apply with respect to further improvement of the existing regulatory framework for software-based products. According to the guidance, the authority conducts a rigorous review of the current premarket requirements, identifying potential issues and developing the steps to be taken to make sure they are addressed properly.
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