Labelling and instructions for use
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website.
Section 5 of Medical Devices Act 719/2021 sets out the language requirements with regard to medical devices and IVD devices in conformity with Regulation 2017/746. Provisions on the language requirements applicable to IVD devices in conformity with the IVD Directive are laid down separately in Act 629/2010.
The information and documents referred to in Article 10(11) of the MD Regulation and Article 10(10) of the IVD Regulation shall be in Finnish, Swedish or English, unless the information is provided in the form of internationally recognised symbols. However, the information necessary for the safe use of the device must be provided in Finnish and Swedish. The manufacturer shall determine by means of a risk analysis which information is necessary for safe use.
Patients for whom a medical device is implanted shall be given an implant card by the healthcare provider. The card shall contain the information allowing the identification of the device, including the device name, serial number, lot number, the Unique Device Identifier (UDI), the device model, as well as the name, address and the website of the manufacturer (Article 18(1) of the Regulation). The information shall be provided in Finnish, Swedish and English.
The language requirements for devices in conformity with the IVD Directive under Act 629/2010 are equivalent: the information accompanying the device shall be provided in Finnish, Swedish or English, unless the information is provided by means of generally recognised instruction or warning labels. However, the information necessary for the safe use of the device must be provided in Finnish and Swedish.
If the MD or IVD device is intended for use by patients or other lay persons, the instructions for use and other information necessary for safe use shall be provided in Finnish and Swedish. The instructions for use and labelling of custom-made devices referred to in the MD Regulation shall be provided either in Finnish or Swedish, or both, according to the user’s needs.
More detailed provisions on labelling and instructions for use are laid down in the Regulations (MDR Annex I, Section 23; IVDR Annex I, Section 20) and in the IVD Directive (Annex I, Section 8, Information supplied by the manufacturer), as well as in the Act on Certain Medical Devices Specified in EU Directives (629/2010; section 12, General obligations of the manufacturer).
Electronic instructions for use
The instructions for use of medical devices may only be provided in a format other than paper under the conditions set out in Regulation (EU) No 207/2012.
The instructions for the use of IVD devices for healthcare professionals can be provided electronically subject to certain conditions. See MEDDEV 2.14/3 rev.1 for more detailed information.
Read more about electronic instructions for use
COMMISSION REGULATION (EU) No 207/2012 on electronic instructions for use of medical devices