There's also a response to a similar question on the Fimea website that you might find helpful:
Referring to your request on the language requirements for medical devices in Finland we would like to give you the following response.
The Chapter 3 paragraph 12 of the Medical Devices Act 629/2010 contains the labelling requirements in Finland: "Information accompanying the device must be in Finnish, Swedish or English, unless the information takes the form of generally known direction or warning symbols. Information intended for users or patients to ensure the safe use of the device must be in Finnish and Swedish. Based on the risk analysis the manufacturer has to specify the information needed to ensure the safe use. The instructions for use and labelling of medical devices intended for selftesting must be in Finnish and Swedish."
The wording of the paragraph is intended to give flexibility for the manufacturer but also to safeguard the user and the patient. The need to use the language of the user depends on the device itself and its intended purpose specified by the manufacturer. The envisaged education and skills of the user are also important criteria.
The manufacturer should address the language issue during the risk analysis that is mandatory for each device. Depending on the results of the risk analysis the manufacturer makes the decisions concerning the labelling. When the device is placed on the market with a CE marking the manufacturer shall continuously monitor the adequacy of the labelling and instructions for use to avoid incidents that could lead to the death or serious deterioration in the state of health of a patient, user or other person. The Chapter 3 paragraph 12 of the Medical Devices Act 629/2010 accepts also English to be used in the labelling. It is the manufacturer's obligation to identify the risks that are related to the language of the labelling. This fact cannot be overruled by exemptions.
We hope that this response helps you in your decision-making.
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Anne LeBlanc
United States
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Original Message:
Sent: 10-Feb-2022 06:14
From: Richard Vincins
Subject: eIFU contents, translation
Hello Anon,
There are 3 or 4 other posts on this topic which has helpful information addressing your question. There is a new/updated regulation EU 2021/2226 concerning eIFU https://eur-lex.europa.eu/eli/reg_impl/2021/2226/oj which defines what products can utilise electronic Instructions for Use (eIFU). Specifically response to your question would be difficult to answer without knowing product type, how your current labelling is established, and what you mean by safety and performance information.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 09-Feb-2022 13:45
From: Anne LeBlanc
Subject: eIFU contents, translation
Anon, can this device be used safely by its intended users without the instructions?
If not, the instructions really need to be in a language they can understand.
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Anne LeBlanc
United States
Original Message:
Sent: 09-Feb-2022 00:25
From: Anonymous Member
Subject: eIFU contents, translation
This message was posted by a user wishing to remain anonymous
Hi,
Our IFU currently runs into more than 100pages and translation is an expensive affair especially with MDR . If we are providing the complete comprehensive contents of the IFU on USB ; can the website and paper copy and also the translations include only safety and performance information .