The article provides an overview of the regulatory policy to be applied to software products and highlights the key points associated thereto. 

The Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority, has published a guidance document dedicated to software and AI as medical devices. The authority acknowledges the important role software (including Artificial Intelligence – AI) plays nowadays and intends to introduce an efficient regulatory framework to ensure that any products placed on the market are in line with the applicable safety and performance requirements. In particular, the document refers to the Software and AI as a Medical Device Change Programme announced by the authority earlier last year. It is important to mention that the said program was developed in the course of the general regulation improvement process that commenced in the UK. 


Regulatory Background 

The present guidance describes in detail the way the aforementioned program will be implemented. According to the document, the Change Programme will deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and the public but also makes sure that the UK is recognized globally as a home of responsible innovation for medical device software looking towards a global market. For this purpose, the authority is going to focus on ensuring that:

  1. The requirements for software and AI as medical devices assure that these devices are acceptably safe and function as intended, thereby protecting patients and the public.
  2. The requirements for manufacturers are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards. 
  3. The friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence (NICE) and NHS England to align domestically, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. The MHRA also mentions that it cooperates with various foreign regulatory agencies in the sphere of medical devices. 

As further explained by the authority, the program described in the guidance is comprised of eleven work packages across two work streams that could be divided as follows:

  1. First stream – eight packages intended to improve the general regulatory framework for software as a medical device (SaMD) products;
  2. Second stream – three packages dedicated to the specific aspects associated with AI-based products (AI as a medical device or AIaMD). 

Policy in Detail 

The document further describes in detail the regulatory policy the authority intends to apply concerning SaMD and AIaMD. In terms of legislation and changes thereto, the approach to be applied will be based on the use of secondary legislation. As a primary solution, the authority is going to issue guidance documents highlighting specific matters and describing the way the respective regulatory requirements should be interpreted and followed by the parties involved. The authority also mentions that various regulatory agencies and governmental bodies were involved in the process of development of the program described herein. Furthermore, the authority intends to engage patients and industry as well. For this purpose, public consultations will be carried out to receive feedback and suggestions. Apart from this, the authority also takes into consideration the regulatory approaches applied in other jurisdictions to ensure alignment when necessary, as well as to use the existing best practices. 

It is also important to mention that some of the instruments the industry representatives will later use to demonstrate compliance with the applicable requirements is currently under development. For this purpose, new standards could be developed, and some of the existing ones could be modified. 



As it was mentioned before, the Changes Programme described herein comprises eleven packages. To assist medical device manufacturers (software developers) and other parties involved, the authority describes each of them in detail and highlights the main points to be taken into consideration. When providing information about each of the modules, the authority indicates a specific issue it is intended to address, the main objectives, and also the specific deliverables. The authority also mentions that the work packages are connected and should be interpreted together. 

The authority summarizes that the main purpose of the packages introduced is to ensure patient and public health protection while creating favorable conditions for new medical devices (especially the ones utilizing novel technologies) to be placed on the market. 

In summary, the present MHRA guidance describes the new policy the authority intends to apply concerning software and AI-based medical devices intended to be marketed and used in the UK. The document provides an overview of the current regulatory framework, indicates the approach the authority intends to apply, and also defines its main goals and objectives. Apart from this, the guidance contains a detailed description of each of the work packages the Change Programme is comprised of to assist industry representatives in interpreting and following the appropriate provisions. 


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