OPINION The recent meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) underscores a pressing issue that plagues the healthcare industry: the shortage of essential…
OPINION The upcoming webinar hosted by the European Medicines Agency (EMA) on the new variations guidelines for marketing authorisation holders marks a significant step in the evolving landscape of healthcare…
OPINION The evolution of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) represents a significant milestone in the regulatory landscape of medicinal products. However, while the service aims to improve pharmacovigilance…
OPINION In the ever-evolving landscape of healthcare, the significance of robust regulatory review practices cannot be overstated. As technology and medical devices advance at a rapid pace, the pre-market review…
OPINION The emergence of personalized medical devices (PMDs) signals a transformative shift in the healthcare landscape, where the focus is increasingly on individualized patient care. The unique characteristics of PMDs…
OPINION The emergence of Software as a Medical Device (SaMD) has transformed the healthcare landscape, offering innovative solutions that enhance patient care. However, the regulatory framework surrounding SaMD is often…
OPINION The recent announcement of the IMDRF Affiliate Membership opens a new chapter for regulatory authorities around the world. This initiative not only facilitates collaboration but also promotes the harmonization…
OPINION The recent outcome statement from the 23rd IMDRF Meeting in Brussels highlights a pivotal moment for regulatory bodies in the medical device landscape. It serves not just as a…
OPINION Post-market activities have long been overlooked in the medical device industry, yet recent discussions highlight their vital importance in ensuring patient safety and product efficacy. The white paper from…
OPINION The IMDRF Strategic Plan 2021-2025 highlights the evolving landscape of medical device regulation, which is crucial for fostering innovation while ensuring patient safety. As technology advances at a breakneck…