Kiri

Dear Barbara,

Thank you for your inquiry.

You are correct, there is no separate obligation for periodic electrical safety checks for medical devices in Estonia that comes from Estonian Medical Device Act.

Nevertheless, I recommend contacting the Consumer Protection and Technical Regulatory Authority and inquiring whether there are such controls or obligations for electrical devices in general (not specifically for medical devices).

Please do not hesitate to contact me for further information or any questions.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

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Dear Sir/ Madam,

I contact you because I would like to know if there is a local regulation that require periodic Electrical Safety Checks (known as MTK / STK in some of the EU countries) for Medical devices in Estonia

I looked into the Estonian Medical device act but I could not find such requirement.

I thank you in advance for your guidance!

Best regards,

Barbara Björkbom

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