News and Updates
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 [...]
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 IFU Medical Device: EU MDR Digital Proposal
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 [...]
CMC Medical Devices at CMEF Shanghai 2025: Meet Us at Hall 8.1 Booth E10!
We’re back at CMEF Shanghai this year! From April 8 to 11, 2025, CMC Medical Devices will be present at one of the world’s largest medical device trade fairs, connecting with industry professionals, manufacturers, and regulatory experts. 📍 Find us [...]
The European Union and MDSAP: A New Opportunity for Medical Device Certification
The Medical Device Single Audit Program (MDSAP) is one of the most ambitious global initiatives aimed at harmonizing regulatory requirements for medical devices. In this context, MedTech Europe and COCIR have recently published a reflection paper urging the European [...]
