These guidelines, introduced under the Good Practice Guide for Qualification and Validation, aim to revolutionize pharmaceutical processes by enhancing efficiency and ensuring compliance with evolving industry standards.
IMDRF releases 2025 terminology document
The “Terminologies for Categorized Adverse Event Reporting” document introduces significant updates for medical device manufacturers, regulatory bodies, and healthcare professionals.
TGA implements unique device identification to enhance medical device safety
TGA in Australia has rolled out the Unique Device Identification (UDI) system, a groundbreaking initiative aimed at improving the traceability and safety of medical devices.
Updated MHRA Guide on Device Registration
MHRA has published updated guidance on medical device registration, specific to the UK market.
White Paper – IEC 62304 2nd edition insights
has officially released the 2nd draft edition of the renowned IEC 62304 standard for medical device software development.
ENISA Assesses NIS2 Cybersecurity Maturity
The European Union Agency for Cybersecurity (ENISA) has released its highly anticipated 2024 Cybersecurity Maturity Assessment for sectors under the NIS2 Directive.
RoHS Exemption Consultation Announced
This consultation specifically addresses the use of mercury in “other discharge lamps for special purposes.”
Italian Court Clarifies “De Facto” Employer in Workplace Safety Cases
The Italian Supreme Court has issued an important clarification regarding the criteria for identifying a “de facto” employer in workplace health and safety criminal matters.
Supplier Management and PFAS Regulations
La Commissione europea presenta il pacchetto omnibus per la semplificazione
TGA Updates Recall Procedure
Effective immediately, the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been officially replaced by the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC).