MDCG has released guidance for classification of medical devices
The document provides practical examples of devices, including applicable rules and classifications.
medical device
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.
MD/IVD Regulation causes changes to national legislation in EU member states
A new Finnish national legislation has entered into force.
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.
Mode of action defines whether your product is a medicinal product or a medical device
Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.
Is your product a medicinal product, a medical device, or both?
Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.