Kiri

Dear Barbara,

Thank you for the additional question.

For this question, I would like to remind you of a manufacturer's definition and what "fully refurbishing" means according to MDR:

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;

‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;

That being said, it is clear that such a device should be handled as a new device, and it shall meet the MDR requirements.

Best regards,

Karl Kalev Türk

Chief Specialist

Department of Medical Devices

Phone +372 5648 5663

[email protected] | [email protected] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear Karl,

Thank you for the info and link that is very useful and provide a clear information about the reprocessing of single use.

In regards of refurbish (to restore and/or refurbish a medical device to the original specifications) if it is possible to commercialized in Estonia aa reconditioned medical device?

I thank you for your support!

Best regards,

Barbara Björkbbom

Dear Barbara,

Thank you for your letter.

Reprocessing of single-use devices (MDR article 17) is not allowed in Estonia.

I am not sure whether you are aware, but information about national rules on reprocessing single-use devices is also made available on the European Commission website - https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/national-rules-reprocessing-single-use-devices_en

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] 

This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.

Dear Sir/Madam,

I contact you because I would like to know if there is any national rule on reprocessing of single use devices in Estonia and if would be accepted the commercialization/shipment of remanufactured products?  if so is there is any document required for notification of remanufactured products  (specific labeling/specific post market surveillance for remanufactured products?

I am not aware if  it is not authorized reprocessing of single-use devices (medical and in vitro diagnostic devices)  on your  territory, and if this coming in the local legislation.

Can you kindly advice?

Thank you

Best regards,

/Barbara Björkbom

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