Mexico: A Summer of Regulatory Overhaul
Translated with AI Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection against [...]
23 09 2025
23 09 2025
23 09 2025
23 09 2025
EU: MDR Language Requirements Tables Updated
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for manufacturers." [...]
27 08 2025
27 08 2025
Medical Advertising in Italy: The New Guidelines
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, [...]
27 08 2025
27 08 2025
IVD Software Qualification: The Team-NB Guide
Translated with AI The Team-NB, the European association of Notified Bodies for Medical Devices, published the second version of its Position [...]
27 08 2025
27 08 2025
Switzerland: UDI Module Activated and Requirements for Procedure Packs
Translated with AI Following the non-extension of the Mutual Recognition Agreement (MRA) with the European Union on May 26, 2021, [...]
06 08 2025
06 08 2025
Guide to Medical Device Printouts: Labels, IFUs and MDR Requirements
According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer [...]
31 07 2025
31 07 2025
Mexico Opens the Door: Shortened Registration for Medical Devices With International Approval
Mexico strengthens its commitment to simplify access to the Medical Devices market. With the publication of Acuerdo nel Diario Oficial de [...]
17 07 2025
17 07 2025
Medical Device Apps: Who Is Responsible? MDCG Guide 2025-4 Provides Clarity
In the field of digital health, Medical Device Software (MDSW) apps are increasingly popular, used by patients and healthcare professionals to [...]
17 07 2025
17 07 2025
Regulation (EU) 2025/1234 Extends eIFUs to All Devices for Professional Use
Instructions for Use (IFU) are a key component of medical device labelling in the European Union, essential for product safety and [...]
10 07 2025
10 07 2025
What is the UDI for Medical Devices and IVDs, and what is it for?
Unique Device Identification (UDI) is a global identification system designed to enhance the traceability and security of Medical Devices and [...]
