Navigating the Changing Regulatory Landscape: Compliance Challenges for Medical Software Suppliers

Suppliers of medical devices and medical software in particular are coming under greater scrutiny from the regulatory authorities as a result of changes to the regulatory environment, most notably the switch from the Medical Device Directive (MDD) to Medical Device Regulations (MDR) and, for UK companies in particular, complicated by Brexit and the need to comply with UK and European regulations.

This is having a major impact on medical software suppliers in 2 ways – (i) interpreting the new regulations to understand the level of compliance required and (ii) the process, cost and timelines to achieve compliance. From its very start, K2 has pursued compliance with the relevant quality and medical device standards and worked diligently to maintain compliance when regulations change.

By May 2024, the remaining MDD Certificates will be voided and in May 2025, no further MDD Certified products will be permitted on the market. We’re well on the way to achieving compliance under the new MDR standards and are well ahead of many other medical software suppliers.

We are proud to hold ISO 13485:2016, UKCA and CE mark compliance which, as the most widely recognised Quality Management standards for medical devices worldwide, demonstrates K2’s ongoing commitment to supplying world-class products and services that consistently achieve exceptional utility and efficiency.

Speaking about our ongoing commitment to achieving compliance, K2’s Managing Director, Mark Hawtin said, “Regulatory compliance has been a long, sometimes challenging but ultimately rewarding journey for K2 – and it’s a never-ending journey. We recognise the importance of adhering to medical device standards for the safety and well-being of patients. We are committed to maintaining the highest level of quality and safety in our products and services, and compliance with standards is a critical component of that commitment. By meeting and exceeding these standards, we can ensure that our products consistently achieve exceptional functionality and performance, ultimately helping to improve health outcomes within maternity.”

It’s clear that many suppliers of medical software will be compelled to comply with changing regulations and the consequences could be very significant to them and hospitals that use their software.

Our purpose is to help improve standards of care for pregnant people and babies by providing maternity professionals with high quality and reliable tools to help better inform clinical decisions at the point of care and eliminate inefficient paper-based processes, helping to significantly lower incidence of poor birth outcomes.

K2’s INFANT-Guardian is already a Class IIa registered medical device. It provides valuable fetal assessment at every bedside – supporting clinicians to capture, communicate and escalate fetal monitoring concern. You can find out more here.

For more information on our Athena system which offers a complete electronic pregnancy journey visit this page.