Noticias y novedades

Important updates for manufacturers and importers: here’s what’s changing! The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 Rev. 2, introducing key changes to the vigilance and post-market surveillance of medical devices and IVDs in the EU. [...]

The Therapeutic Goods Administration (TGA) continues to modernize Australia's regulatory system, introducing measures that simplify market access for medical devices and in vitro diagnostics (IVDs). Here’s what’s new and how these updates can impact your business. What’s Changing for Manufacturers? [...]

The Medicines and Healthcare products Regulatory Agency (MHRA) has released official guidance to help medical device manufacturers prepare for the updated Post-Market Surveillance (PMS) requirements, effective June 16, 2025. What is PMS? PMS is a mandatory system designed to [...]

Lithium batteries are a critical technology for powering mobility devices such as electric wheelchairs and mobility scooters. However, if not managed properly, they can pose significant risks, including fire hazards that endanger users’ safety. To address these concerns, the MHRA [...]

As of January 1, 2025, the amended Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) comes into force, aligning with European Union (EU) regulations and restoring regulatory equivalence between Switzerland and the EU. This update has significant implications for [...]

EUDAMED Registration: Your Step-by-Step Guide Compliance with European regulations is essential for placing medical devices on the market, and registering in the EUDAMED database is a key component of this process. Whether you’re new to EUDAMED or need clarity on [...]

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 [...]

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 [...]

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 [...]