Prohibitions and Penalties in Medical Device Regulations

Importers and distributors of medical devices have specific obligations outlined in the MDR and IVDR regulations. Additionally, the Polish Medical Devices Act of April 7, 2022 provides a list of prohibited activities, with severe penalties for non-compliance.

Prohibited Activities for Importers and Distributors of Medical Devices

According to the Polish Medical Devices Act of April 7, 2022, importers and distributors are prohibited from:

  • Marketing and distributing products that have exceeded their expiration date or the recommended maximum number of uses specified by the manufacturer.
  • Marketing products with expired, withdrawn, or suspended certificates of conformity.
  • Supplying and making point-of-care diagnostic devices and in vitro diagnostic devices available to laypersons for self-use, except for self-testing devices and sample containers.
  • Supplying products, systems, and procedure packs in Poland that are not intended for the Polish market.
  • Finalizing sales contracts outside of their business premises. However, they are allowed to conduct sales within the consumer’s home, but only upon explicit invitation by the consumer. In such cases, sales should be limited to the customer’s home and should not take place elsewhere.

Penalties for Non-compliance with Statutory Prohibitions on Medical Devices

If a violation of the prohibitions poses a threat to public health or patient safety, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products may prohibit the marketing of medical devices and order the withdrawal or discontinuation of devices already available on the market. The importer or distributor found responsible for violating these prohibitions is obligated to bear the costs associated with the required actions. Failure to comply with the President’s decision can result in fines of up to PLN 250,000.

Restrictions on Labeling of Medical Devices

Article 7 of the MDR Regulation and the IVDR Regulation prohibit the inclusion of information on labels and in instructions that may mislead users or patients. This includes ascribing functions and properties to devices that they do not have or suggesting uses for the device that are not aligned with the intended purpose established during the conformity assessment process. Violations of this prohibition can result in fines of up to PLN 5,000,000.

Misleading information in product advertising is also prohibited. Violators of this prohibition may face penalties of up to PLN 2,000,000.

Administrative Penalties for Non-Compliance with Obligations

The Polish Medical Devices Act of April 7, 2022, specifies the range and severity of penalties applicable to importers and distributors in case of non-compliance.

The highest penalty is imposed for marketing or using a device that fails to meet the requirements of the MDR or IVDR regulations. In such cases, the penalty amount ranges from PLN 20,000 to PLN 5,000,000.

Fines of up to PLN 50,000 are imposed when:

  • The importer or distributor fails to provide the manufacturer with information regarding received notifications or complaints.
  • The importer or distributor does not retain a copy of the declaration of conformity for the required duration.
  • The importer or distributor fails to cooperate with the competent authority.

If an importer or distributor places a product on the market or makes it available, knowing or having reason to believe that the product does not comply with the legal requirements, and neglects to notify the manufacturer, the authorized representative, and the competent authorities about the non-compliant and potentially high-risk nature of the product, the penalty can reach up to PLN 250,000.

Importers can face similar penalties when they neglect to include their data on the product, when their markings hinder the legibility of the manufacturer’s information, or when they fail to complete their data in the electronic system.

Distributors and importers failing to ensure proper storage and transportation conditions for products may face fines of up to PLN 250,000.

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