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The Estonian Health Board Terviseamet oversees device regulation in Estonia.CLASSIFICATION SYSTEM: Medical devices are divided into Classes I, IIa, IIb, and III based on the level of risk they pose.
TIMEFRAME: For Class I devices, the registration procedure takes roughly 4-6 weeks after submission. The agreement with the notified body and the type of equipment govern the other classes.
The Estonian Health Board, or Terviseamet in Estonian, oversees the regulation of medical equipment there. The State Agency of Medicine once had responsibility over both drugs and medical devices.
Since then, however, the State Agency of Medicine has maintained to oversee medications for both human and veterinary use, while the Terviseamet has assumed authority of the regulation of medical devices.
Estonia uses the same risk-based medical device classification methodology as the rest of the EU member states. In Estonia, medical equipment fall within one of four categories: Class I, Class IIa, Class IIb, or Class III. The lowest danger is related with Class I devices, whereas the highest risk is associated with Class III devices.
Estonia medical devices market accounted for $XX Billion in 2023 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
Aiming to encourage the use of next-generation Software as a Medical Device solutions and position Estonia at the forefront of this rapidly expanding market, DTx Estonia is an industrial partnership of Estonian digital therapeutics makers.
DTx products use evidence-based, clinically tested software to directly provide therapeutic interventions to patients in order to manage, treat, and prevent a wide range of diseases and disorders. We think Estonia has a special chance to play a significant role in the global DTx market.
The goal of DTx Estonia, an association of companies that produce digital therapeutics, is to promote cross-industry cooperation and increase awareness of evidence-based digital medicines. The Estonian Health Economy Association is a nonprofit umbrella organisation whose goal is to foster the sector’s rapid expansion.
