Tecnología Médica
Mapa TecMedTecnología Médica
Share your views: Consultation on the draft guidance on managing applications for medical device licences
13/03/2025 -
Consultation for draft guidance document on managing applications for medical device licenses.
Pre-market guidance for machine learning-enabled medical devices
13/03/2025 -
This document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III and IV MLMD under the regulations.
Guidance on terms and conditions for class II to IV medical devices
13/03/2025 -
Overview of regulatory authorities and guidance on T&Cs for medical device licences under Medical Device Regulations
Medical Devices Directorate Quarterly Performance Report for Q2 and Q3 2024-25
13/03/2025 -
The Medical Devices Directorate quarterly performance reports provides detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards.
Portable X-Ray Unit FDR Xair
11/03/2025 -
The residual risk information of the XD2000 provided was not sufficient. There is the potential defectiveness for users to be exposed to unnecessary radiation by unintended handheld use. The users...
AK 96 and AK 98 Dialysis Machines
18/02/2025 -
Baxter Healthcare Corporation (Baxter) is issuing an urgent medical device correction for the AK 96 and AK 98 dialysis machines with the self-care configuration listed below due to the potential for...
CODMAN® Surgical Strips and Patties X-Ray Detectable
29/10/2024 -
During an internal investigation, Integra Lifesciences identified higher than expected levels of endotoxin within the raw material used to product CODMAN® Surgical Patties and Strips that may have...
