Health Technology

MDCG has released guidance for classification of medical devices

The document provides practical examples of devices, including applicable rules and classifications.

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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.

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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.

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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. 

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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. 

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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.

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Notified Body – A business-critical relationship

Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.

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