Understanding the Medical Device Registration in Poland

Regulatory Authority

Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL)

The President of the Office is a central government administration authority responsible for approving medicinal products for marketing, making biocidal products available, placing devices on the market, conducting clinical trials, medical devices, in vitro diagnostic medical devices, and notifications.

They are responsible for implementing Regulations 2017/745 and 2017/746, and for notified bodies. The President of the Office’s principles and area of operation are specified in the Act on the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products of March 18, 2011.

The Office’s operations are outlined in the Act on the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products of March 18, 2011.

Link for Regulatory Authority

https://www.urpl.gov.pl/pl/wyroby-medyczne-1

Local Regulation

Act on Medical Devices (20 May 2010)

Classification of Medical Devices

Class I, IIa, IIb and III

Listing or Registration Requirements

Manufacturer/ an authorized representative with a place of residence or registered office in the territory of the Republic of Poland shall notify the product to the President of the Office at least 14 days before placing it on the market or submitting the first product for evaluation.

Documents Required

Any device intended to be distributed in Poland should have both labeling and instructions for use provided in Polish. However, the information contained in the labeling could be provided with the help of harmonized symbols.
At the same time, if the foreign medical device is intended to be used in the particular healthcare facility that applies for its approval, such device could be supplied with the labeling and instructions for use provided in English, while the information that is intended for patients should be provided in Polish.
If the labeling of the device is provided in Polish, the instructions for use could be provided either also in Polish or described with the help of harmonized symbols.
If the labeling placed on the package containing more than one medical device (group or batch packaged) is provided in Polish, the labeling of each particular device could be provided either in Polish or with the help of harmonized symbols.
Authorizations and assessments, Conformity Assessment, Technical Documentation.

Registration Timeline

The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.

License Validity

5 Years

Special Labelling Requirements

Products intended for use on the territory of the Republic of Poland have markings and instructions for use in Polish or expressed by means of harmonized symbols or recognizable codes.
It is allowed that devices intended for use in the territory of the Republic of Poland, provided to healthcare providers, with their written consent, have markings or instructions for use in English, except for information intended for the patient, which is given in Polish or expressed with harmonized symbols or recognizable symbols. Codes.
If the marking of the product is in Polish, the instructions for use of the product are also in Polish or in the form of harmonized symbols or recognizable codes.
If the marking of the collective packaging is in Polish, the marking of the unit packaging is also in Polish or in the form of harmonized symbols or recognizable codes.