Noticias y novedades

The Medical Device Single Audit Program (MDSAP) is one of the most ambitious global initiatives aimed at harmonizing regulatory requirements for medical devices. In this context, MedTech Europe and COCIR have recently published a reflection paper urging the European Union [...]

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 [...]

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 [...]

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 [...]