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February 5, 2026
Approximately 5 minutes
Estonian Guidance on Language Requirements and Market Access for Medical Devices
1. Background and Purpose
The Estonian State Agency of Medicines acknowledges the challenges manufacturers face in transitioning from directives to Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR), including stricter requirements, timelines, and member state-specific language obligations. The letter urges manufacturers not to deprioritize smaller markets like Estonia based on market size projections. Source: Letter to Manufacturers (25 February 2025) https://www.ravimiamet.ee/sites/default/files/documents/2025-02/Letter_to_manufactures_25022025.pdf
2. Estonian Language Requirements
Under the Estonian Medical Devices Act §16:
- For devices intended for lay users: Information necessary for safe use must be in Estonian.
- For professional users: Estonian or English is acceptable.
- For custom-made devices: Language understandable to the specific user. Remaining information may be in another EU/EEA language understandable to users. Source: Letter to Manufacturers (25 February 2025) https://www.ravimiamet.ee/sites/default/files/documents/2025-02/Letter_to_manufactures_25022025.pdf
3. Compliance Options for Lay User Devices
The Agency encourages practical approaches:
- Manufacturer fully translates and labels.
- Cooperate with local distributors for relabelling/repackaging under manufacturer control (MDCG 2021-26 clarifies that full Article 16 requirements do not apply to subcontracted operators).
- Distributors fulfill Article 16 obligations independently (QMS, notified body certificate, notifications). Local distributors can facilitate communication and activities. Source: Letter to Manufacturers (25 February 2025) https://www.ravimiamet.ee/sites/default/files/documents/2025-02/Letter_to_manufactures_25022025.pdf
4. Professional User Devices
English-only information is acceptable, with encouragement to use local distributors for any needed Estonian support. Source: Letter to Manufacturers (25 February 2025) https://www.ravimiamet.ee/sites/default/files/documents/2025-02/Letter_to_manufactures_25022025.pdf
5. Agency Goal and Contact
The Agency aims to ensure safe and effective device supply in Estonia comparable to larger states, inviting direct consultation at mso@ravimiamet.ee. Source: Letter to Manufacturers (25 February 2025) https://www.ravimiamet.ee/sites/default/files/documents/2025-02/Letter_to_manufactures_25022025.pdf
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