News & Insights

Introduction Since application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) in May 2022, CDx manufacturers, medicine sponsors, notified bodies, national competent authorities ... Read more

Considerations for Sponsors Navigating a Shifting Landscape Read more

Authored By: Beaufort Contributor On 27 November 2025, the European Commission published Commission Decision (EU) 2025/2371, formally confirming that the first four modules of EUDAMED—Actor Registration, ... Read more

EU and U.S. Regulatory Considerations for Post-Market Advertising and Promotion of IVDs Authorized in vitro diagnostic medical device (IVD) claims must be supported by a defined ... Read more

Authored by: Beaufort Contributor The AMDM IVD Focus Fall Meeting brought together regulators, industry leaders, and diagnostic professionals for two days of focused discussion and actionable ... Read more

MedTech Clinical Trial Readiness eBook Read more

Point-of-Care (POC) diagnostic trials for influenza are unlike any other — and within Beaufort’s infectious disease CRO services, they represent some of the most operationally demanding ... Read more

What It Means for FDA Operations and the Diagnostics Industry Authored by: Beaufort Contributor When the federal government shut down on October 1, 2025, the U.S. ... Read more

Insights from the IVD Track at MedTech Summit 2025 The IVD track at MedTech Summit 2025 in Berlin brought together regulators, notified bodies, and industry experts ... Read more

Authored by: Beaufort Contributor From MDUFA to EUDAMED—What Regulatory Leaders Need to Know The 2025 AMDM Annual In Vitro Diagnostics (IVD) Regulatory Meeting delivered two full ... Read more

Updates to the UK Medical Device Regulations Authored by: Beaufort Contributor The regulatory landscape for medical devices, including in vitro diagnostics (IVDs), in the United Kingdom ... Read more

Strengthening our Commitment to Successful Client Outcomes Nilufer Celenk, Vice President, Clinical Program Management Beaufort is excited to welcome Nilufer Celenk, as Vice President of Clinical ... Read more