Vastuskiri

Dear Ms. Björkbom,

It is true that for professional use only, the IFU-s and labelling of a medical device do not require translation to Estonian language unless professional users request these documents in Estonian langugage.

However, for implantable devices not specified in Article 18 (3) of the MDR, additional language requirements apply as per Estonian Medical Devices Act § 32⁴ (1):

 (1) The manufacturer of a medical device shall prepare the implant card delivered with an implantable medical device not specified in subsection 3 of Article 18 of Regulation (EU) 2017/745 of the European Parliament and of the Council in Estonian and provide the information required in points b–d of subsection 1 of Article 18 and the information necessary for a health care professional for filling in the implant card either in Estonian or translated into Estonian.

Therefore, implant cards, information required in points b-d of Article 18 (1) of the MDR and any other information necessary for a health care professional to fill in the implant card must be provided in Estonian language only.

All the best,

Dear Sir/Madam,

I am contacting you in regards to the language requirements for implantable products.

I understand that in accordance with national legislation for products that are for professional use only, the documents that come with them ( IFU and labeling) may be provided in Estonian, although the end user always has the right to receive the documentation in Estonian if requested.

For implantable products that are for professional use only, in addition to the instructions for use and labels, there are other series of documentation available such as the implantable card itself, the PIL and the SSCP, and I would like to know  if there is also the possibility that this additional documentation is provided in English as well.

I have reviewed the local legislation in a translation available in English of the Estonian MD Act and  art 32.4  states that “The manufacturer of a medical device shall prepare the implant card delivered with an implantable medical device not specified in subsection 3 of Article 18 of Regulation (EU) 2017/745 of the European Parliament and of the Council in Estonian and provide the information required in points b–d of subsection 1 of Article 18 and the information necessary for a health care professional for filling in the implant card either in Estonian or translated into Estonian”

Since the word Estonian is repeated twice, I don't know if it means that they can be provided in English or translated into Estonian.

I would be grateful for your guidance on this topic.

I thank you in advance for your support.

Best regards,

/Barbara Björkbom.

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