Under IMed's Lens - December 2024
IMed Consultancy Ltd
QA/RA Medical Device & IVD Consultancy UKRP - QMS - MDR - IVDR - ISO 13485 - CE Marking - Global Submissions - UKCA
Highlights from 2024
We started 2024 with a free whitepaper on In-Vitro Diagnostics (IVDs)!?
With the deadline to certify Class D devices under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (‘IVDR’), on 26 May 2025, around the corner, and estimates suggesting that the entire certification process for legacy products could take between 12 and 18 months, manufacturers need to act urgently to ensure they are not cut out of the market. The paper, available here analyses the key role of IVDs in supporting healthcare systems with early diagnosis to tackle common and rising diseases and comes at a critical time for manufacturers that still have not started the process of registering legacy devices under the EU IVDR.
In June we published a whitepaper exploring regulatory challenges for AI and ML in medical devices and digital health products
From wearable sensors that monitor vital signs to AI-powered diagnostic tools, the range of innovations is vast and promises to revolutionize healthcare delivery. Regulators are thus striving to keep pace with technological advancements, while addressing concerns regarding data security, potential bias and safety impacts possible from poorly performing clinical software tools.
As a result, navigating the evolving regulatory landscape poses challenges for manufacturers implementing AI and ML, especially as digital health solutions can blur the lines between medical devices and non-medical tools. Understanding the expectations of regulators and assessing the strategic considerations necessary for incorporating AI into a device may also prove key to ensuring a smoother launch into the market.
Our Digital Dilemmas whitepaper sheds light on the complex and confusing regulatory state of play for AI and Machine Learning-powered medical devices internationally.
Jonathan Ripley stepped into the Managing Director role at IMed Consultancy
In June, Jonathan Ripley became the new Managing Director of IMed Consultancy. The previous MD, Leeanne Baker is focusing on a more strategic Group role as the new Chief Executive Officer of IMed as the Group expands.
Team day 2024
On September 12th, IMed’s team got together for a day dedicated to reviewing our goals for the year ahead at @Oxford Trust, a local hub supporting innovators in developing their technology and products.
We’re now ready to face all 2025 has in store for us, and we’re more committed than ever to supporting innovative businesses and cutting-edge technology!
What we talked about in our blog during the year:
Success stories
Did you know we have a page dedicated to clients’ success stories on our website?
From NHS-born innovation to digital health technologies, we support medical device and in vitro medical device manufacturers to drive innovation, improve patient care and outcomes worldwide, providing assistance through all stages of the product lifecycle from: from concept and design through clinical studies and post-market surveillance.
Curious? Find all success stories here, or dive into a specific one by clicking on one of the links below:
Our December blog ??
AI and ML in medical devices and digital health products: a new era of healthcare delivery
AI and ML are transforming healthcare—from early disease detection and personalized treatments to remote patient monitoring and robotic surgery. This new era of digital health holds immense potential, but navigating the regulatory challenges is critical for safe and effective innovation.
In our December blog, we explore key applications, opportunities, and insights into adapting to evolving global regulations like the EU AI Act, FDA initiatives, and the UK regulatory sandbox.
Read more on the subject in our whitepaper “Digital Dilemmas: Regulatory challenges for Artificial Intelligence and Machine Learning in medical devices and digital health products” and make sure to follow us on LinkedIn to not miss the third and final instalment of this series, focused on regulations.