Since 26 May 2021, the Regulation (EU) 2017/745 on medical devices directly applies in Poland as the implementing law is yet to be introduced. Previously the Council Directive 93/42/EEC concerning medical devices was introduced into the Polish legal system by the Act of 20 May 2010 on medical devices and supplementary laws, which are currently still in force.
On 19 October 2021, the Council of Ministers adopted the draft law on medical devices submitted by the Minister of Health to adapt obsolete Polish rules to the new EU Regulation.
The critical solutions introduced by the new Act cover:
- The President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products is the competent authority within the meaning of Article 101 and Article 96 of Regulation 2017/745 who will issue administrative decisions in situations specified by EU regulations.
- The President of the Office will request information about medical devices from public health institutions and entities conducting such trade or using these devices. The President of the office can request information for the list of custom-made medical devices that have been made available on the Polish territory.
- Sponsors shall direct all applications for clinical trials and their modifications carried out in Poland to the Institutional review board.
- Reprocessing of single-use devices – the new Act introduced a ban on the use of reprocessed single-use devices in Poland.
- The Act introduces a system of administrative penalties for non-compliance. Violation of the new Act on medical devices and EU Regulations’ requirements regarding the placement of devices on the market, service, and production will be subject to financial penalties. By way of an administrative decision, the President of the Office will impose financial penalties.
General regulatory requirements on placing medical devices on the Polish market:
Registration of devices
- Until EUDAMED is fully functional, there is an obligation to notify devices by manufacturers/producers and authorized representatives (AR) residing or having its registered office in Poland and to register by importers and distributors with Polish registered addresses. The notification concerns all risk classes of medical devices. If the distributor or the importer does not have a residence or registered office in the territory of the Republic of Poland and a medical device was registered in one of the member states, neither manufacturer nor distributor needs to notify Polish Competent Authorities.
The manufacturer or AR shall submit the device to the President of the Office of Ministry of Health (MOH) at least 14 days before it is placed on the market or before the first product is submitted for evaluation.
- The manufacturer shall translate to Polish language labels and instructions for use. The English language is permitted only for devices for professional use.
- Information regarding a device should be available on the manufacturer’s website to identify the product and its manufacturer. It should include any safety and performance information relevant to the user or other person.
The draft Act on medical devices was recently referred to the Special Committee in Sejm for further work before going through other steps of the Polish legislative process.
You can find the legal text in our dedicated Library of Documents – LAW.
- Enterprise Europe Network (March 2021). Wyroby medyczne na rynku Unii Europejskiej. Retrieved on 13.12.2021 from https://www.parp.gov.pl/attachments/article/69435/EEN_Wyroby_medyczne_na_rynku_Unii_Europejskiej.pdf
- Projekt Ustawy o wyrobach medycznych. (October 2021). Draft Act on medical devices. Retrieved on 20.12.2021 from https://www.gov.pl/web/premier/projekt-ustawy-o-wyrobach-medycznych2
- Chancellery of the Prime Minister (November 2021). Draft Act on Medical Devices. Retrieved on 13.12.2021 from https://www.gov.pl/web/premier/projekt-ustawy-o-wyrobach-medycznych