News and Updates
IVD Classification: What’s new in the latest MDCG 2020-16 Rev.4 guidance?
In March 2025, the Medical Device Coordination Group (MDCG) released an update to its guidance MDCG 2020-16 Rev.4, focused on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). This document plays a crucial [...]
MHRA publishes its first monthly safety bulletin for medical devices and medicines
In March 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched the first issue of its new monthly safety bulletin, a step forward in making critical safety information more transparent and easier to access. This initiative is particularly [...]
Hemodialysis bloodlines shortage: FDA alert and clinical implications
The U.S. Food and Drug Administration (FDA) has recently issued a communication to healthcare providers regarding an ongoing shortage of hemodialysis bloodlines, a critical component in both acute and chronic dialysis treatments. These devices, responsible for connecting a patient’s blood [...]
Conditional CE certificates: A new pathway for faster market access?
Over the past few years, the medical device industry has been navigating a complex regulatory landscape with the implementation of MDR 2017/745 and IVDR 2017/746. While these regulations have strengthened safety and performance standards, they have also created a bottleneck [...]
Data integrity in medical device testing – A critical FDA concern
Why data integrity in medical device testing is more important than ever The FDA’s Center for Devices and Radiological Health (CDRH) has recently intensified its scrutiny of data integrity in medical device testing, and for good reason. The agency has [...]
AI and medical devices: The UK defines a new regulatory path
Artificial Intelligence is transforming the healthcare industry, providing increasingly sophisticated tools for diagnosis, monitoring, and treatment. However, with the rising adoption of AI-powered medical devices, ensuring safety and effectiveness has become a top priority. Recently, the UK government took a [...]
New recall procedures in Australia: what changes with PRAC?
March 5, 2025, marked a significant step forward in the regulation of medical device recalls in Australia. The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC), replacing the previous Uniform Recall Procedure [...]
UK IVD Registration: Key Updates for Manufacturers with Expiring CE Certificates
New MHRA guidance on in vitro diagnostic (IVD) device registration in the UK The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on the registration of in vitro diagnostic (IVD) devices with expiring CE certificates. These [...]
Electronic Instructions for Use (e-IFU): The European Commission proposes a digital shift for medical devices
Is the era of paper-based instructions coming to an end? The European Commission has launched a public consultation to update the regulation on electronic Instructions for Use (e-IFU). If adopted, all medical devices intended for healthcare professionals could use digital-only [...]
