MDCG has released guidance for classification of medical devices
The document provides practical examples of devices, including applicable rules and classifications.
Health Technology
The device and certification module of EUDAMED is now open for registration and searches!
The EUDAMED device module was launched across the Europe on 4 October 2021, but the transition periods are defined on national level.
Assessing the biological safety is a measure that protects both the user and manufacturer of a medical device.
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.
MDCG has released guidance for performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVD)
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 Finnish Medicines Agency FIMEA has issued a new administrative regulation on economical operator and device registrations for medical devices
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.
Do you know which designation codes are applicable to medical devices manufactured by your company?
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.
Notified Body – A business-critical relationship
Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.