MHRA Guidance on SaMDs: Navigating the Regulatory Landscape

Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. There is a growing need to have clearly defined requirements and guidelines on how to regulate this new type of medical product. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has taken significant steps in providing the industry with guidance documents on regulatory requirements on SaMD. In this article, we cover the advancements of these guidance documents and discuss what we found to be helpful for manufacturers based on a variety of topics.

Insights into MHRA regulations for SaMDs

Often with new technologies, innovation is one step ahead of regulations and standards. As an emerging product group, this is especially true for SaMDs, and even more so, Artificial Intelligence (AI) as a Medical Device (AIaMD). This can bring challenging a situation for SaMD manufacturers, as they struggle to comply with laws and standards they have outgrown. Luckily, SaMD manufacturers are not on their own, and Competent Authorities are recognizing their problems.

MHRA change programme for SaMD’s

We specifically want to commend MHRA, which has started work on its “Software and AI as a Medical Device Change Programme” or “Change Programme” for short.

The Change Programme focuses on the following three aspects: 

• • Writing requirements that address the safety and performance of SaMDs; 
  • Requirements are clearly defined, and it is clear how to demonstrate compliance, as supported by guidance documents and designation of standards; 
  • Alignment of requirements between the National Institute for Health and Care Excellence (NICE), NHS England, and IMDRF. 

Their aim: “To protect patients and the public whilst ensuring that we accelerate responsible innovation.” 

Currently, there are 8 work packages (WP) defined, each with a clear problem statement: 

1. WP 1 Qualification 
2. WP 2 Classification 
3. WP 3 Premarket requirements 
4. WP 4 Post Market 
5. WP 5 Cyber Secure Medical Devices 
6. WP 9 AI Rigour 
7. WP 10 Project Glass box (AI Interpretability) 
8. WP 11 Project Ship of Theseus (AI Adaptivity) 

Guidance documents

Many of these WPs have guidances and Best Practice documents as deliverables, which we expect that will significantly contribute to easing regulatory compliance activities by manufacturers.

As regulatory experts with SaMD experience, we are incredibly excited about the work MHRA puts into resolving these pressing issues. We are especially looking forward to the proposal for a regulatory sandbox for SaMD to gather premarket evidence under a high level of monitoring, and a Best Practice document aligned with IEC 62304 that MHRA is creating in collaboration with the British Standards Institution (BSI).

It is great to hear about the collaboration with multiple institutions and the awareness of global best practices. Ultimately, manufacturers, users, and patients alike will profit the most from clear requirements that are internationally harmonized.

So far, project has resulted in the following guidance documents: 

• • Medical device stand-alone software including apps,
    • This guidance addresses a.o. Qualification, Classification, Essential Requirements, Post Market Surveillance, Labelling.

• • Crafting an intended purpose in the context of SaMD
    • This Guidance details the Key Elements of an Intended Purpose (structure and function of the device, intended population, intended user, and intended use environment) and specifies the level of detail expected from an Intended Purpose statement. Additionally, common issues are discussed about SaMD’s Intended Purposes.

• • Reporting adverse incidents involving Software as a Medical Device under the vigilance system
    • In this guidance, o.a. examples are given of reportable incidents, and an explanation is given on three types of reports.

• • Good Machine Learning Practice for Medical Device Development: Guiding Principles 
    • This guidance document contains the 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP), applied to Medical Devices.

Learn more about UK MHRA and SaMDs with Medenvoy

If you have any questions regarding placing your software devices on the UK market, require relevant training or consulting services, or are looking for a UK Responsible Person to contract, get in touch. 

Related articles

• • Medical Device Stand-Alone Software Under the UK MHRA
  • Responsibilities of a SaMD Importer
  • Medical Device Software in the EU: A Guide to Compliance and Market Entry