In brief
1 July 2023 saw the last provisions of the Act of 7 April 2022 on Medical Devices (“MD Act“) enter into force. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (“Office“) launched two new online platforms: a list of distributors and a list of users of medical devices. Moreover, since 1 July also an obligation of manufacturers, authorized representatives and importers of custom-made devices to register their activities in Poland before placing such device on the market also came in force.
Contents
Key takeaways
Polish regulator of the medical devices market has launched new online registration systems intended for:
- distributors of medical devices, systems or procedure packs,
- professional users bringing medical devices, systems and procedure packs to Poland,
- manufacturers, authorized representatives and importers of custom-made devices.
Although the systems became operational on 1 July 2023, some of them have not yet become mandatory for the users, due to certain transition periods provided for in the MD Act. During the transition periods, the companies may follow the previously applicable registration procedures which remain in force on a temporary basis.
Non-compliance with the new obligations can attract a financial penalty of up to PLN 200,000 (EUR 44,500).
List of distributors and users of medical devices
The following two platforms have been launched on the website of the Office:
- a list of distributors of medical devices, systems or procedure packs based in Poland, as referred to in Article 21 of the MD Act (link), where entities distributing medical devices will be obliged to create an account and submit information about the first introduction of devices onto the Polish market
- a list of users of medical devices, i.e., a system designed to collect information on devices, systems and procedure packs verified brought into the territory of Poland by entities or persons performing medical activities and other entities that use medical devices for business or professional activities as referred to in Article 22 of the MD Act (link)
Registration takes place online. An access code (login) is generated once an account has been created and an application form is sent to the e-mail address provided during registration. The application form needs to be printed and signed by hand or electronically by a person or persons authorized to represent the entity.
The application can be submitted: (i) in person at the Office, or (ii) electronically via an electronic public services (ePUAP) using the trusted profile of the person representing the entity, or (iii) electronically, using the qualified electronic signature of the person representing the entity, to the e-mail address: urpl@urpl.gov.pl, or (iv) by ordinary mail.
Once the data has been verified, the account will be activated. Information on activation will be sent to the e-mail address provided at registration along with the password.
With respect to medical devices, systems or procedure packs made available on the territory of Poland for the first time (and not notified before 1 July), the distributor will provide the following data:
- Basic UDI-DI code of the medical device, system or procedure pack,
- name and address of the manufacturer,
- type and trade name of the medical device, system or procedure pack
– within seven days from the date of introducing the medical device, system or procedure pack into the territory of Poland.
Custom-made devices – registration of activities
As of 1 July 2023:
- a manufacturer of a custom-made device
- an authorized representative of a manufacturer of a custom-made device who is not domiciled or established in a Member State
- an importer of a custom-made product
– are obliged to submit an application for registration of their activities to the Office before placing a device on the market.
The obligation applies to entities that are domiciled or seated on the territory of Poland.
The application for registration should be submitted by a person authorized to represent a given entity or by a proxy in one of the following ways:
- by means of the dedicated online platform maintained by the Office
- in person at the Office, showing respective proof of identity (ID, passport)
- in electronic form through the ePUAP platform using the trusted profile of the person representing the entity
- in electronic form using the qualified electronic signature of the person representing the entity to the e-mail address: urpl@urpl.gov.pl, or signed using a personal signature (i.e., advanced electronic signature verified by the personal signature’s certificate)
- signed by the person representing the entity and certified by a notary public (in the form of a letter
An application submitted by an authorized representative must be accompanied by: (i) an extract from the relevant business register that is no more than three months old, legalized by the respective consul of Poland or apostilled, (ii) authorization of the person representing the entity and the rules of representation executed before a notary public or other publicly trusted entity no earlier than three months before the submission and legalized by the respective consul of Poland or apostilled, (iii) the appointment referred to in the Article 11(1) of the MDR or IVMDR. All the above documents need to be translated by a sworn translator.
If the dedicated system operated by the Office is used, an access code (login) will be generated once an account has been created and an application form will be sent to the e-mail address indicated during registration. The form must be printed out, signed and submitted to the Office as specified above.
After data verification, the account will be activated. Information on the activation will be sent to the e-mail address provided at registration, along with the password.
Transition period
The MD Act assumes a transition period lasting until 30 June 2024, during which the distributors and manufacturers, authorized representatives and importers of custom-made devices have a choice – notification can be filed under the previously applicable rules or using the new online platform.
After 30 June 2024, it will only be possible to discharge the registration obligation by using the new registration procedures referred to above. The transition period means that the devices notified to the Office on the basis of previously applicable regulations are not subject to registration in the new system.
Sanctions
Non-compliance with the new obligations can attract a financial penalty of up to PLN 200,000 (EUR 44,500).
