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UDI codes are a unique identification code that allows you to read information about a medical product unambiguously and efficiently. For which products, categories or groups should UDI codes be collected and stored? Within the scope of the common European policy on medical devices, the leading ones are the Regulations of the European Parliament and of the Council: (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostic medical devices. In Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, Article 27(8) provides that economic operators are to retain and store, preferably in electronic form, the UDI codes of the devices which they have supplied or which have been supplied to them if those devices are Class III implantable devices.

On the other hand, in order to ensure the harmonised application of the UDI system, the Commission may, by means of implementing acts, extend that obligation to additional products, categories or groups of devices to which the requirement to retain and store UDI codes is to apply.

On the other hand, in Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices, we find Art. Article 24(8). It is similar to the one mentioned above, but it is only in a blanket form and indicates only the Commission’s power to determine the devices, categories or groups of devices to which the obligation to retain and store UDI codes is to apply.

Both of the above regulations agree that the Commission may freely shape the obligation to collect and store UDI Codes.

We must also not forget about the Polish regulation – the Medical Devices Act. Art. Article 18 of the Medical Devices Act mostly refers to the above-mentioned EU regulations, but there are two key issues.

Firstly, the preservation and storage of UDI codes is to be carried out in electronic form. This is an important difference from European law, where only such a form is recommended.

The second important issue is the fact that the Minister of Health may specify that the obligation to preserve and store UDI codes is to be broader than it results from the EU regulations. The Minister of Health should be guided by the protection of life or health and the safety of users of devices and patients.

As Duraj Reck & Partners Law Firm has been able to determine, through the Ministry of Health and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Department of Information on Medical Devices, none of the indicated institutions has extended the obligation to collect and store UDI codes to include additional types of devices, categories or groups of devices. It should be emphasised that the answer given to us indicated that such work is not even currently being carried out.

To sum up, currently the obligation to retain and store UDI codes applies only to class III implantable devices and has not yet been extended by either the Polish Minister of Health or the European Commission.