News and Updates
IvDO Update 2025: Key Changes in Swiss In Vitro Diagnostic Regulations
As of January 1, 2025, the amended Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) will take effect, aligning with European Union (EU) regulations and restoring regulatory equivalence between Switzerland and the EU. This update significantly impacts IVD [...]
Team-NB Guide December 2024: Your Complete Resource for Medical Device Certification
On December 18th, 2024, Team-NB, the European Association of Medical Device Notified Bodies, released an important guide for manufacturers seeking medical device certification under the EU Medical Device Regulation (MDR 2017/745). This publication provides clear and actionable guidance on [...]
Arab Health 2025: Join Us in Dubai!
We’re excited to announce our participation in Arab Health 2025, one of the most prestigious global events in the healthcare and medical device industry. This international exhibition brings together healthcare professionals, innovators, and industry leaders from around the world to [...]
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 the effectiveness, efficiency, relevance, and coherence of the EU regulations on medical devices (Regulation 2017/745) and in vitro diagnostic devices (Regulation 2017/746). This is a key opportunity for stakeholders to [...]
Important Update on Medical Device Regulation in the UK
The UK government has outlined a roadmap for a new regulatory framework that prioritizes patient safety and ensures access to safe and innovative medical devices. Here are the key dates to keep in mind: 📌 2024 Implementation of priority [...]
Master UDI-DI for Contact Lenses: What Manufacturers Need to Know
Learn about the new Master UDI-DI for contact lenses: requirements, Eudamed registration, and mandatory compliance timeline.The Master UDI-DI system is an essential development for the contact lens industry, providing a streamlined approach to traceability and ensuring compliance with the [...]
Streamline Your Compliance Process with the New CAPA Template – MDCG 2024-12
The MDCG 2024-12 template is a vital tool for managing Corrective and Preventive Actions (CAPA) under MDR and IVDR. By providing a structured framework, this template simplifies the process of addressing non-conformities (NCs) and ensures organizations remain compliant with the [...]
Post-Market Surveillance (PMS): A Key Pillar for Compliance and Innovation in the Medical Device Industry
In the rapidly evolving field of medical devices, compliance with Post-Market Surveillance (PMS) requirements has become a cornerstone of safety, innovation, and market competitiveness. However, a recent report by the Health and Youth Care Inspectorate (IGJ) paints a concerning picture: [...]
Is the FSC valid indefinitely, or does it have an expiration date?
If you’re a medical device manufacturer, understanding the validity of your FSC (Free Sales Certificate) is crucial for maintaining market access and ensuring regulatory compliance. What Is the Free Sales Certificate (FSC)? The FSC is an essential document that [...]
