IVDR compliance deadline: how to prepare your Quality Management System (QMS) by May 26, 2025
With the entry into force of the Regulation (EU) 2017/746 [...]
UDI-DI mandatory from May 26, 2025: A guide for manufacturers
An important deadline is coming up under the EU Medical [...]
Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance
Understanding the Clinical Evaluation Report (CER) When it comes to [...]
CDSCO speeds up the process: automated certificates for medical devices
India has introduced a new step toward regulatory efficiency in [...]
The UK reclaims a leading role in clinical research: What this means for medical device and IVD manufacturers
In recent years, the clinical research landscape in the [...]
Post-Market Surveillance: A Swiss perspective on critical compliance gaps
We’ve previously highlighted how important post-market surveillance (PMS) is, not [...]
IVD Classification: What’s new in the latest MDCG 2020-16 Rev.4 guidance?
In March 2025, the Medical Device Coordination Group (MDCG) [...]
MHRA publishes its first monthly safety bulletin for medical devices and medicines
In March 2025, the UK’s Medicines and Healthcare products [...]
Hemodialysis bloodlines shortage: FDA alert and clinical implications
The U.S. Food and Drug Administration (FDA) has recently [...]
Conditional CE certificates: A new pathway for faster market access?
Over the past few years, the medical device industry has [...]
