GDPR Data Protection Impact Assessment (DPIA) Template for EU Medical Devices
Chinese manufacturers exporting medical devices to EU countries must meet not only the MDR (EU Medical Device Regulation) but also
Regulatory News
Global medical device regulatory updates and registration guides
The New EU ESPR Regulation Is Here
The New EU ESPR Regulation Is Here: Fully Replacing Ecodesign – Will Every Product Be Affected? For more than a
EU Data Act Transparency Statement Template for Medical Devices
The EU Data Act (Regulation (EU) 2023/2854) has applied in full since 12 September 2025. According to Recital 14, medical
EU PMS Data Collection Template
EU PMS (Post-Market Surveillance) is the systematic, proactive and continuous monitoring system that manufacturers must establish under the EU Medical
EU Data Act Contract Terms Template
The EU Data Act (Regulation (EU) 2023/2854) has applied in full since 12 September 2025. This article focuses on Article
Introduction to the EU Data Act
The EU Data Act (Regulation (EU) 2023/2854) is the core legislation of the EU data strategy. It entered into force
EU Data Act: Use Cases and Applications
The EU Data Act has applied in full since 12 September 2025. Its core use cases are built on four
Introduction to the ISO/IEC 27701 Standard
ISO/IEC 27701 is an international standard that defines a management system designed to help organisations protect privacy when processing personal
The Relationship Between ISO 27701 and Regulation (EU) 2016/679
Chinese manufacturers exporting medical devices to EU countries must meet the MDR (EU Medical Device Regulation). Article 110 in Chapter
EU Plans to Substantially Simplify the MDR: What Will Change for Certificates, Clinical Evidence and Notified Body Audits?
Over the past two years, what has frustrated companies most about the MDR/IVDR has not been “demanding requirements” but “blocked