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MHRA Updated Guidance on Software: Understanding Medical Device Status and Regulation

Updated: Jun 19, 2023

In the ever-evolving field of medical devices, software applications (apps) are playing an increasingly significant role. To ensure the safety and effectiveness of these apps, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on software regulations. In this blog post, we will delve into the MHRA's latest guidance, exploring when software apps are considered medical devices and how they are regulated. Stay informed and discover how to navigate this dynamic landscape effectively.


Understand the MHRA's criteria for software as a medical device (SaMD) and how it differs from hardware medical devices. Discover the key factors that determine whether a software app qualifies as a medical device, including its intended purpose and usage. Gain clarity on the regulatory implications and obligations for software apps designed for medical purposes such as diagnosis, prevention, monitoring, treatment, or alleviation of disease.


Uncover the different risk classifications and corresponding regulatory pathways outlined by the MHRA. Learn about the specific requirements for Class I, IIa, IIb, and III software apps, based on their associated risks and intended use. Understand the importance of providing clinical evidence to demonstrate safety, performance, and effectiveness for higher-risk software apps. Get insights into the role of notified bodies and conformity assessments for certain classifications. Distinguish between standalone software apps and accessory software in terms of their regulatory obligations. Gain an understanding of the unique requirements and considerations for each type. Explore how standalone software apps are evaluated based on their intended purpose, while accessory software apps are assessed in relation to their role in supporting or supplementing the performance of hardware medical devices.


With the MHRA's updated guidance on software as a medical device, stakeholders in the software app industry can navigate regulations effectively and prioritize patient safety. Stay informed, comply with the appropriate regulatory requirements, and implement robust post-market surveillance systems. Embrace collaboration and international harmonization to drive innovation and facilitate market access. For the latest information and accurate guidance, refer to the MHRA's official website and resources.


Additionally, for manufacturers and developers seeking support and guidance in navigating the regulatory landscape for software medical devices, AF Pharma can provide valuable assistance. AF Pharma is a trusted partner that offers expertise in regulatory affairs and compliance for medical devices. Their knowledgeable team can help streamline the process of classifying software apps as medical devices, ensuring compliance with MHRA regulations, and meeting the necessary requirements for market approval. By partnering with AF Pharma, manufacturers and developers can receive comprehensive support and guidance to navigate the complexities of software app regulation effectively.


Are you a manufacturer or importer of medical devices seeking a reliable partner to fulfill your legal obligations in the UK market? Look no further than AF Pharma, your trusted UK Responsible Person. With our extensive expertise and in-depth knowledge of the regulatory landscape, we are committed to ensuring your medical devices meet all necessary compliance requirements.

At AF Pharma, we understand the complexities and challenges associated with navigating the ever-evolving regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA). Our dedicated team of experts will work closely with you to streamline the process, ensuring your devices meet the highest standards of safety, quality, and effectiveness.


As your chosen Responsible Person, AF Pharma will meticulously handle all aspects of compliance, including maintaining up-to-date technical documentation, monitoring the performance and safety of your devices on the market, and facilitating effective communication with the MHRA. With our strong rapport and understanding of regulatory authorities, we will represent your interests with professionalism and integrity.


Partnering with AF Pharma means gaining a competitive edge in the UK market, as our team stays abreast of the latest regulatory changes and ensures your devices remain compliant throughout their lifecycle. We are committed to fostering a long-term relationship built on trust, transparency, and mutual success.

Don't let regulatory complexities impede your entry or growth in the UK medical device market. Choose AF Pharma as your UK Responsible Person, and let us navigate the regulatory landscape for you, allowing you to focus on what matters most – developing innovative and life-changing medical devices. Contact us today to discover how we can support your business's success.

Software as medical device
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MHRA UPDATED GUIDANCE ON SOFTWARE
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