How to identify a medical device?

Only medical devices that are in conformity with the requirements may be placed on the market and put into service in Finland and in the EU area. Before placing a device on the market, the manufacturer must verify its safety, suitability for the intended use and performance. A CE marking is a proof that the device is in conformity with the applicable requirements.  

Before placing a medical device on the market, the manufacturer must affix the CE marking visibly, legibly and indelibly to the device or its packaging. If a product does not bear the CE marking required by law or the marking is non-compliant, the product may be ordered to be withdrawn from the market. This does not apply to custom-made devices or investigational devices which do not bear a CE marking. 

For some medical devices, a notified body must perform a conformity assessment. In this case, the CE marking must be accompanied by the 4-digit identification number of the notified body.

Devices under MDR or IVDR must have a Unique Device Identification (UDI), which is a unique numeric or alphanumeric code specific to a medical device. It allows for unequivocal identification of devices on the market and facilitates their traceability. The UDI can also be in the form of a barcode, QR code or other machine-readable code. Due to transitional periods related to the medical device regulations, there may still be some devices on the market without an UDI.  

Medical devices must be accompanied by instructions for use. An exception to this is situations where it is safe to use the device without instructions for use or instructions for use have been provided in electronic format.  If the use of a device requires the user to read the instructions for use, the manufacturer must indicate this with the ‘Consult instructions for use’ symbol. 

According to Section 5 of the Medical Devices Act (719/2021), labelling and instructions for use of medical devices must be available 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. If the device is intended for use by patients or other consumers, the instructions for use and other information necessary for safe use must be available in Finnish and in Swedish. The instructions for use and labelling of custom-made devices referred to in the MDR must be either in Finnish or Swedish, or both, according to the user’s needs. 

Implant cards provided to users of implanted devices must include information allowing the identification of the device (the device name, serial number, lot number, the UDI, the device model, name, address and the website of the manufacturer) in Finnish, Swedish and English. 

More information about the labelling and instructions for use of medical devices can be found on the pages intended for manufacturers and distributors.

Device manufacturers

Device distributors and importers