Tag: AI

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Key Regulatory Dates for your 2025 diary

The changeable regulatory environment for Medical Devices and In vitro Diagnostic medical devices (IVD) is showing no sign of slowing down as we begin 2025.

The UK Government agency, the Medicines & Healthcare products Regulatory Agency (MHRA) have already provided us with a Roadmap towards the future regulatory framework for medical devices, published on 9 January 2024, recently updated in December 2024.

Given the expectation that these dates are targets, and may change, we can expect the following updates throughout 2025:

January 2025 – Public Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices closes on 05 January 2025.

March 2025 – Publication of new guidance on UK Post-Market Surveillance regulation.

March 2025 – New guidance of use of Exceptional Use Authorisation, including the potential changes in EUA for Covid-19 tests under CTDA.

April 2025 – Potential MHRA Fees change (link to consultation)

April 2025 – Published response on public consultation on UK Post-Market Surveillance regulation.

May 2025 – Certificates issued in accordance with IVD Directive (98/79/EC) Annex VI which shall become void at the latest on 27 May 2025 and can not be used for placing CE marked IVDs on the Great British Market.

June 2025 – Post Market Surveillance Statutory Instrument in force (PMS)

June 2025 – Development of draft guidance on artificial intelligence (AI) development and deployment

Winter 2025 – Statutory Instrument on Pre-Market Requirements

With so much change happening, it has never been so important to engage with your regulatory teams, to understand the impact and implications of the changes and to get ahead of the game. IVDeology work with IVD manufacturers throughout the global industry to Educate, Evaluate and Execute regulatory strategies to Sustain market access.

You can get in touch with IVDeology by booking time with our friendly team here or email i[email protected] – we’d be happy to chat

We also have a series of online webinars that can also support your next steps and understanding of the regulatory landscape, you can check the early 2025 sessions here:

Importance of the role of PRRC (person responsible for regulatory compliance) under MDR and IVDR – 23rd January 2025 The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR Training Course

2 day online Introduction to the Invitro Diagnostic Regulation (IVDR) webinar – 5th and 6th February 2025 Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

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The AI Airlock Programme – The Potential of AI in Healthcare

The Potential of Artificial Intelligence in Healthcare

Artificial Intelligence (AI) in healthcare has the potential to improve patient outcomes, for example, by improving diagnosis or treatment selection. However, it is difficult to assess new and innovative AI technology using traditional trial techniques.

The AI Airlock

In Oct 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that they would set up a regulatory sandbox, the AI Airlock. This will provide software and AI medical device developers with virtual testing environments in which they can design and implement test protocols for their devices. There will be three different testing environments (Simulation airlock, Virtual airlock and Real-world airlock) and different factors will determine which testing environment will be most appropriate to each candidate and their device. MHRA’s AI Airlock webinar, presented in July 2024, provides more details about the AI Airlock.

By bringing together expertise from innovators, regulatory organisations including Approved Bodies, Government, the NHS and academia, the AI Airlock pilot program will allow for a collaborative approach. This will enable developers to generate robust evidence for their technology and assist in safe development and deployment of such devices.

Devices will need to meet one or more of the following eligibility criteria:

  • Has the potential to deliver benefits for patients
  • Device or concept application is innovative
  • Presents a regulatory challenge
  • Device is conceptually/developmental robust and ready to be trialled.

Four to six candidates will be recruited to join the pilot cohort and there is no fee for application or participation in the pilot program. Candidates will need to commit resource to the pilot program and are expected to fund their own studies and delivery of any Airlock testing, including accessing relevant data sets. Whilst this pilot phase of the AI Airlock will run until April 2025, candidates should expect to complete their individual Airlock testing within 6 months.

Learnings from this first pilot programme will inform future Airlock phases and the outputs will include:

  • Project Reports from each candidate project team,
  • An Airlock Sandbox report of learnings to inform future guidance and implications for the regulatory framework,
  • A programme evaluation report sharing learnings on the use of regulatory sandboxes. 

Application to the MHRA

This is a great chance for software and AI medical device developers to obtain advice from regulators whilst they experiment and testing their device in controlled and safe environments. Participation in the programme also offers developers an opportunity to have a part in informing the future GB regulatory framework on software and AI medical devices.   

Candidates can now apply to the MHRA to join the AI Airlock pilot program by completing the application form and returning it to [email protected]  before 07 October 2024.

If you’re looking at developing an AI product, or any other diagnostic device, please do get in touch as we can support you from idea to design and market – you can contact us here for a complimentary introduction chat

Written by Tsz Wai Woo, Regulatory specialist at IVDeology