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The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes perform these that purposes without being part of a hardware medical device.
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Software for which the manufacturer claims a specific medical intended purpose. Such software has a CLINICAL BENEFIT and requires CLINICAL EVIDENCE within its own conformity assessment.
- Section 57. General Background
- Section 58. Scope and Definitions
- Section 59. Distance Sales
- Section 60. Classification: Risk Categorisation
- Section 61. Classification: Airlock Classification Rule
- Section 62. Pre-Market Requirements
- Section 63 - Post-Market Requirements
- Section 64 - Samd Cyber Security
- Section 65 - Artificial Intelligence as A/In A Medical Device
Background
57.1. Software as a medical device (SaMD, being standalone software and software included in wider hardware) (including AI as a medical device (AIaMD)) has grown in market share and complexity. Increasingly it has applications in health and social care that could not have been envisioned when existing regulations around medical devices were developed. 57.2. The current medical device regulations contain few provisions specifically aimed at regulating SaMD or AIaMD. Our proposal is that the UK...
Possible Changes and Questions
58.1. To clarify the meaning and scope of term “software” we propose adding a new definition to the UK medical device regulations. In that context we propose adding the following definition of ‘software’ to the UK medical devices regulations: “a set of instructions that processes input data and creates output data”. This definition is consistent with the definition in this Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand a...
Possible Changes and Questions
59.1. SaMD can be deployed to UK by websites, app stores and via other electronic means including deployment from websites hosted in other jurisdictions. We are considering whether regulatory change is needed to clarify or add to the requirements for placing SaMD on the market in these circumstances. In particular we are proposing that the definition of “placing on the market” could be modified to clarify when SaMD deployed on websites, app stores (for example Google Play and Apple stores) an...
Possible Changes and Questions
60.1. We propose to change the classification of SaMD to ensure the scrutiny applied to these medical devices is more commensurate with their level of risk and more closely harmonised with international practice. We propose to follow (with minimal adaptations to suit the UK context) the risk categorisation (and associated definitions) in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. 60.2. We anticipate this will require up...
Possible Changes and Questions
61.1 We are also considering introducing an ‘airlock classification rule’. This is a provision that would allow for a temporary classification to be applied to some SaMD (which is likely to involve monitoring and restricting the SaMD as if it were a high-risk device) where the risk profile is unclear. This could allow early access to market for novel and innovative SaMD whilst ensuring the safety of users and patients until the risks of the device are properly understood. Q61.1. Do you think...
Possible Changes and Questions
62.1. SaMD is subject to essential requirements that apply to medical devices more broadly. We want to ensure software as a medical device (SaMD) receives adequate pre-market scrutiny to assure its safety, quality and performance and ensure the essential requirements in place meet this need. Q62.1. Do you consider additional essential requirements should be in place to assure the safety and performance of SaMD specifically? (‘Yes’ / ’No’ / ’Don’t Know/No Opinion’) Q62.2. Please set out, and e...
Possible Changes and Questions
63.1 We are proposing: a. that, in order to allow accurate and swift reporting via the Digital Yellow Card Scheme, SaMD should have a hyperlink to MHRA endorsed websites where a person can ‘report an adverse incident with a medical device’ where appropriate, and b. that certain SaMD change management processes such as ‘predetermined change control plans’ should be provided for. Q63.1 Do you think the UK medical devices regulations should mandate a ‘report adverse incident’ link as set out abo...
Possible Changes and Questions
64.1 We want to ensure SaMD has sufficient cyber security and information security both for the purposes of the direct safety of the device (from the perspective of, for example, whether its functioning could be tampered with) and also the security of personal data held on or in relation to the device. We are therefore proposing that manufacturers of SaMD be required to meet certain minimum requirements relating to security measures and protection against unauthorised access. Q64.1 Do you con...
Possible Changes and Questions
65.1 AIaMD is a subset of software as a medical device. Given this, MHRA views the changes noted above as also having benefits for the regulation of AIaMD. In addition, we are considering other changes to the Regulations specific to AIaMD. For example, we propose amending the Regulations to require performance evaluation methods for diagnostic AI which would take a comparable approach to performance evaluation methods used for in vitro diagnostic medical devices in terms of requiring demonstr...
Released by the Commission services in January 2012 (and updated in July 2016), the document provides practical advice to manufacturers, organisations and public authorities on how to determine when a software falls under the definition of a medical device or of an in-vitro diagnostic medical device.
What is software as a medical device? The Medical Device Regulation (MDR) is fully in force from May 2021. Alongside extensive provisions relating to physical medical devices, the MDR also applies to any software that meets the definition of a medical device.
Aug 26, 2020 · Standalone software and apps that meet the definition of a medical device are required to be CE marked in accordance with the EU regulatory requirements in order to ensure they are safe to use and perform in the intended manner.
Aug 8, 2014 · Guidance on what a software application medical device is and how to comply with the legal requirements. Read our statement on the launch of the guidance.
