Module 17 2024

05/12/2024

Chapter 10: Software as a Medical Device

The government remains interested in the potential introduction of an airlock conditional authorisation and intends to consider this further, taking into account the feedback raised by consultation respondents. The MHRA plans to scope further detail about this possible change and include it in a possible future public consultation to obtain further feedback from stakeholders before potentially adding it to the UK regulations. Pre-market requirements The regulations will introduce further essential requirements to assure the safety and performance of SaMD specifically: • Cyber security - our policy position is to include cyber security as an essential requirement. • Data protection, privacy, or confidentiality - we will work closely with the Department for Digital, Culture, Media & Sport (DCMS), the Information Commissioner’s Office, the National Data Guardian, and the Health Research Authority to ensure that patient data is protected.

The Organisation for Professionals in Regulatory Affairs

69

69

• Better alignment to Data Coordination Board (DCB) standards - shifting essential requirements to match DCB standards would risk international divergence for the benefit of national convergence. We shall instead work with NHS Digital and NHSX to map and align where possible, also using guidance to better harmonize with these standards. • We consider requirements specific to AI as a medical device are best clarified via guidance on how to meet a GSPR akin to EU MDR’s GSPR 17.2 (which includes verification and validation) rather than setting up a separate essential requirement/GSPR specific to AI as a medical device. Chapter 10: Software as a Medical Device

A key feature of this approach will be the introduction of essential requirements/GSPRs that closely mirror EU MDR, Annex I, GSPR 17.

The regulations will not separate out essential requirements/GSPRs for software but subdivide the essential requirements/GSPRs for software, largely mirroring the EU MDR.

The Organisation for Professionals in Regulatory Affairs

70

70

35