MDCG has released guidance for classification of medical devices
The document provides practical examples of devices, including applicable rules and classifications.
The document provides practical examples of devices, including applicable rules and classifications.
The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.
The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.
The content of released guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.
The new regulation implements the obligations set out in medical device EU-regulations (2017/745 and 2017/746) and in national legislation 719/2021 in Finland.
When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.
Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.