Noticias y novedades
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 [...]
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 [...]
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 Union [...]
New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the recent designation of two new Notified Bodies (NBs): CNCps (Spain) – Now designated for IVDR (EU Regulation 2017/746), increasing certification capacity for in vitro diagnostic devices. NSAI (Ireland) – Becomes the [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant new opportunity for manufacturers of Class III and Class IIb active medical devices. This initiative, developed in collaboration with the European Commission, provides scientific support to companies to optimize their [...]
