MEDICAL DEVICES
Liz Harrison, BSI’s Global Head of IVD Devices, leads a global team of regulatory product experts, reviewers, and decision-makers across all types of in vitro diagnostic medical devices. With a background in molecular biology and deep expertise in infectious disease, human genetic testing, cancer, and companion diagnostics, she brings scientific depth and operational clarity to IVDR implementation. Liz’s leadership ensures that BSI’s conformity assessments reflect both regulatory expectations and clinical realities, supporting manufacturers in navigating complex evidence requirements with confidence and precision.
Going forward, oversight by a notified body is no longer the exception but the norm.
Emerging trends shaping Class C devices The regulatory environment will continue to evolve. AI-driven diagnostics will require robust validation datasets and continuous learning controls. Digital health integration will expand post market surveillance obligations. Companion diagnostics will demand synchronised regulatory strategies across drug/device combinations. Early engagement with a highly established,
proactive notified body such as BSI, positions you to stay ahead of these evolutions.
Act early to shape your future The 2026 IVDR deadline is closer than it appears when viewed through the lens of internal development cycles and the intrinsic complexity of Class C devices. Delaying engagement risks regulatory setbacks, loss of market share, and erosion of stakeholder confidence. This
The MDR transition showed what happens when limited capacity meets immature submissions: incomplete dossiers, long rounds of questions, and multi-year delays in market access
About BSI BSI sets new standards for success by collaborating with a diverse range of clients and partners across multiple industries to help them enhance performance, meet regulatory expectations and achieve their goals. BSI is able to guide organisations through the complexities of global requirements. As the world’s first national standards body, its unrivalled global expertise and commitment to public benefit and innovation set the benchmark for regulatory excellence.
www.bsigroup.com
is the new reality for Class C: prepare earlier, demonstrate more, manage continuously. BSI is ready to be your strategic expert. Our technical expertise, proactive communication, and proven track record provide the confidence needed to navigate the IVDR transition. Take the first step today: contact BSI
to schedule a meeting. Share a high- level overview of your Class C device and documentation status, and begin a collaborative, transparent journey, that turns early engagement into regulatory compliance. The future of in vitro diagnostics will be PPi
defined by those who act now.
April 2026
WWW.PATHOLOGYINPRACTICE.COM 39
AdobeStock / ultramansk
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56
