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REPUBLIC OF EST0NA MINISTRY OF SocIAL AFFAIRS Anna Eva Ampelas European Commission sante-med-dev@ec. europa. eu DG for Health and Food Safety Our ref. 02.01.2023 No 1.4-2/3-1 Brussels 1049 Beigium Notification in accordance with the Regulation (EU) 2017I745 and Regulation (EU) 20171746 Dear Mrs. Ampelas, In accordance with the Reguation (EU) 2017/745 on medical devices Articles 111 and 113 and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Articles 104 and 106, Estonia is notifying the national legal provisions on Ievying of fees and penalties. Amendments to the Medical Devices Act and Other Acts were adopted on 7.12.2022, changes were introduced to the levies foreseen in the State Fees Act and to the fees foreseen in Medical Devices Act and to the penalties foreseen in the Medical Devices Act. The other acts communicated by letter Our ref. 02.01.2023 No 1.4-2/3-1 remain unchanged. Consolidated texts of English transtations of following Estonian legislation are not yet available, therefore the texts in English must be considered unofficial. The Amendments to the Medical Devices Act and Other Acts (https://www.riiqiteataja.ee/akt/122122022002) entered into force on 1 January 2023, the national legal provisions are as following: 1. Regulation (EU) 2017/745 Article 111 and Regulation (EU) 2017/746 Article 104 (Ievying of fees) 1.1. State Fees Act (levies on acts performed based on the Medical Devices Act): § 298. Review of applications for clinical trial of a medical device and for performance study of an in vitro diagnostic medical device (1) A state fee of 210 euros shall be paid for the review of an application for clinical trial of a medical device. (2) A state fee of 210 euros shall be paid for the review of an application for performance study of an in vitro diagnostic medical device. § 2982. Issuing of a certificate of free sale and duplicate of a certificate of free sale (1) A state fee of 154 euros shatl be paid for issuing a certificate of free sale within 45 working days as of the date of receipt of the application. (2) A state fee of 32 euros shall be paid for issuing a duplicate of a certificate of free sale. (3) A state fee of 308 euros shall be paid for issuing a certificate of free sale within five working days as of the date of receipt of the application. § 298. Review of an application for designation and notification of conformity Suur-Ameerika 1 / 10122 Tallinn / ESTONIA / +372 626 9301 / [email protected] / www.sm.ee / Reg. no 70001952 assessment body, notification of designating a conformity assessment body and issuing an operating permit (1) A state fee of 2509 euros shall be paid for reviewing an application for designation and notification of conformity assessment body. (2) A state fee of 777 euros shall be paid for notfying of designating a conformity assessment body and issuing an operating permit. 1.2. Medical Devices Act (corresponding paragraphs and subsections regulating state levies and fees): § 22. Application for the right to conduct investigation and introducing substantial modifications of investigation (2) The sponsor of clinical investigation of a medical device shall pay a fee to the ethics committee for giving an ethical opinion on the application for investigation and notifying of substantial modifications of an investigation. (3) The fee specified in subsection (2) of this section shall be determined by the ethics committee on the basis of the fo(Iowing conditions: 1) the fee cannot be more than 3000 euros; 2) the size of the tee has been determined based on the costs related with the delivery of an opinion; 3) the size of the fee has been made pubticly available. (5) The sponsor shall be required to pay: 1) state fee for a review of the application with the rate provided for in the State Fees Act; 2) a fee for professional assessment of investigation to Health Board specified in subsection (10) of this section before submitting an application of investigation; 3) a tee for professional assessment of introducing substantial modifications of investigation to Health Board specified in subsection (10) of this section before submitting a notification of substantial modifications of investigation. (10) The Iist and fee rates of expert opinions, professional assessment of investigation and professional assessment of introducing substantial modifications of investigation shall be established by a regulation of the minister responsible for the area. The Iist and fee rates referred to in subsection (10) wiII be established in following regulation of the minister responsible for the area. The regulation of the minister responsible for the area is yet not established. § 32. Fees for the assessment of the application and on-site assessment of the applicant and monitoring and re-assessment of notified bodies (1) An applicant, whose application for designation is complete, must pay the Health Board a fee for the assessment of the application and on-site assessment of the applicant specified in subsection (4) of this section. (2) A notified body, who is registered in Estonia, must pay the Health Board a tee for monitoring and re-assessment of notified bodies specified in subsection (4) of this section. (4) The size of the fees and procedure for calculation and payment of the fees of the assessment of the application and on-site assessment of the applicant and monitoring and re-assessment of notified bodies shall be established by a regulation of the minister responsible for the area. The fees referred to in subsection (4) wiII be established in following regulation of the minister responsible for the area. The regulation of the minister responsible for the area is yet not established. 2(3) 2. Regulation (EU) 2017/745 Article 113 and Regulation (EU) 2017/746 Article 106 (penalties) Medical Devices Act (corresponding paragraphs and subsections regulating penalties): § 36. Limit of penalty payment In the event of failure to comply with a precept, the upper limit of penalty payment imposed pursuant to the procedure provided for in the Substitutive Enforcement and Penalty Payment Act shall be 32 000 euros. § 39. Violation of requirements for placing on the market, making available on the market, in-house manufacturing, distribution, and professional use of medical devices (1) Violation of the requirements for the placing on the market, making available on the market, in-house manufacturing, distribution, or professional use of medical devices is punishable by a fine of up to 200 fine units. (2) The same act, if committed by a legal person, is punishable by a fine of up to 32 000 euros. § 391 Violation of requirements for conduct of a clinical investigation of medical device and performance study of in vitro diagnostic medical device (1) Violation of the requirements for the conduct of clinical investigation of medical device or performance study otin vitro diagnostic medical device is punishable by a fine of up to 300 fine units. (2) The same act, if committed by a legal person, is punishable by a fine of up to 32 000 euros. Yours sincerely A / . 7/. Heidi Alasepp Deputy Secretary General on Health Maret Voore +372 6269 366 [email protected] 3 (3)