New Notified Bodies for MDR & IVDR: CNCps and NSAI strengthen EU Certification
The European certification system continues to expand with the [...]
New EMA Procedure: Scientific Advice for High-Risk Medical Devices
The European Medicines Agency (EMA) has introduced a significant [...]
MDCG 2023-3 Rev. 2: Everything you need to know about the new vigilance rules
Important updates for manufacturers and importers: here’s what’s changing! [...]
Australia: New opportunities for medical device and IVD manufacturers
The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory [...]
MHRA updates Post-Market Surveillance: How to adapt your medical devices to new requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has released [...]
How to Ensure the Safety of Mobility Devices with Lithium Batteries: MHRA Recommendations
Lithium batteries are a critical technology for powering mobility [...]
IvDO Update 2025: Key Changes in Swiss In Vitro Diagnostic Regulations
As of January 1, 2025, the amended Swiss Ordinance [...]
Team-NB Guide December 2024: Your Complete Resource for Medical Device Certification
On December 18th, 2024, Team-NB, the European Association of [...]
Arab Health 2025: Join Us in Dubai!
We’re excited to announce our participation in Arab Health 2025, [...]
Public Consultation on the Evaluation of EU Regulations for Medical Devices and In Vitro Diagnostics: Have Your Say!
The European Commission has initiated a public consultation to assess [...]
