News and Updates

The European certification system continues to expand with the recent designation of two new Notified Bodies (NBs): CNCps (Spain) – Now designated for IVDR (EU Regulation 2017/746), increasing certification capacity for in vitro diagnostic devices. NSAI (Ireland) – Becomes [...]

The European Medicines Agency (EMA) has introduced a significant new opportunity for manufacturers of Class III and Class IIb active medical devices. This initiative, developed in collaboration with the European Commission, provides scientific support to companies to optimize their [...]

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 monitor [...]

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 [...]

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 [...]

What is EUDAMED Registration? EUDAMED Registration is a crucial step for medical device manufacturers, importers, and Authorized Representatives aiming to comply with European regulations. The European Database on Medical Devices (EUDAMED) is a centralized system designed under the Medical [...]

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 the [...]