Obligations of Medical Device Distributors in Spain
The obligations and responsibilities of medical device distributors have changed with the entry into force of the MDR. The demands on the obligations of medical device distributors have increased, and it is estimated that market surveillance by the competent authority of each country …
Obligations of Medical Device Distributors in Spain
The obligations and responsibilities of medical device distributors have changed with the entry into force of the MDR. The demands on the obligations of medical device distributors have increased, and it is estimated that market surveillance by the competent authority of each country …
UDI Medical Product
https://www.devicesistemas.com/wp-content/uploads/2021/09/asesoramiento-udi-espanfa-device-sistemas.jpg What is the UDI? The UDI is a Unique Identification System for Medical Products that allows for the exact identification of the product and facilitates its traceability throughout the product’s life cycle, from its design and manufacturing or development to after it has been marketed. Objectives of the UDI The objective of the […]
Products without Medical Purpose. Annex XVI MDR
https://www.devicesistemas.com/wp-content/uploads/2021/07/medicina-device-sistemas.jpg A couple of days ago, we attended the talk organized by @Fenin related to Products Without Medical Purpose to which the Regulation (EU) 745/2017 on Medical Devices applies. The talk was really good and clarified doubts that many of us had regarding these products. These are the conclusions we drew from the talk: 1. […]