EHDS Regulation Published: Key Benefits for EU Healthcare
The European Health Data Space (EHDS) Regulation ((EU) Regulation 2025/327 amending Directive 2011/24/EU and Regulation (EU) 2024/2847) has…
Resources & News
Stay informed with real-time regulatory news and expert insights, and keep the conversation going by connecting with us on social media.
Showing 82–90 of 229
IMDRF Releases Consolidated Adverse Event Reporting Terms
The International Medical Device Regulators Forum (IMDRF) has released a consolidated document for Categorized Adverse Event Reporting (AER),…
GMDN Launches Arabic Version of Medical Device Nomenclature
We are excited to announce the official launch of the Arabic version of the Global Medical Device Nomenclature…
New Updates to HPRA Certificate of Free Sale Process
The National Competent Authority of Ireland, Health Products Regulatory Authority (HPRA), has updated the application certificate of free sale…
Swissmedic’s Focus Campaign: Key Outcomes on PMS Compliance
Swissmedic conducted a focus campaign to assess compliance with the post-market surveillance (PMS) requirements of the Medical Devices…
New IVD Registration Update Under MHRA
Under a new guidance document the EU provided new guidance for the EU IVDR transition extension under Article 110. This…
EMDN MDCG 2025 Update: New Guidance for Medical Devices
The EMDN MDCG 2025 update has been released, incorporating feedback from the 2024 Public Consultation and the MDCG Nomenclature Working…
Swiss Medtech: Net-Zero Roadmap for Medical Device Firms
As of January 2024, The Climate and Innovation Act (KIG) has officially come into force, setting a clear pathway for…
Australia 2024 Update: Market Authorization for Medical Devices
An update to Australia’s guidance on the use of market authorization evidence from overseas regulators for medical devices, including in-vitro…
Showing 82–90 of 229