Prohibited Actions Under the Medical Devices Act

Article 61 of the 2022 Polish Medical Devices Act lists specific actions that are prohibited regardless of the device class or distribution channel. Common violations include:

  • placing devices on the market after their expiry date or beyond the declared number of uses,
  • distribution of products with withdrawn, suspended, or expired certificates,
  • making bedside or IVD devices available to laypersons when not intended for self-testing,
  • placing system or procedure packs intended for other EU markets,
  • selling products outside company premises without documented customer invitation.

These cases often result from ineffective QMS control and failure to involve the PRRC in pre-market verification processes.

Misleading Information – MDR and IVDR Restrictions

According to Article 7 of MDR and Article 7 of IVDR, all information accompanying a device—labels, IFU, marketing communications, and promotional materials—must not mislead users. It is forbidden to:

  • attribute functions or therapeutic effects not supported by the technical documentation,
  • suggest off-label uses,
  • falsely represent clinical results or claim compliance with unmet standards.

All user communications must align with the clinical evaluation or performance evaluation (for IVDs), per MDCG 2021-27. Publishing misleading materials can result in fines up to PLN 2,000,000, and placing a non-compliant device on the market may incur penalties of up to PLN 5,000,000.

Administrative Penalties for Operational Violations

The Act imposes additional financial penalties on importers and distributors who fail to meet MDR/IVDR operational obligations:

  • failure to report complaints or adverse events to the manufacturer – up to PLN 50,000,
  • not storing the declaration of conformity – up to PLN 50,000,
  • refusing to cooperate with regulatory authorities – up to PLN 50,000.

Failure to integrate these responsibilities into the quality management system (QMS) may be considered a systemic breach, triggering audit findings.

Penalties for Marketing Non-Compliant Products

The most severe penalties relate to technical and regulatory non-compliance. They apply to both manufacturers and economic operators:

  • fines ranging from PLN 20,000 to 5,000,000 for placing non-compliant devices on the market,
  • up to PLN 250,000 for importers/distributors who fail to act on suspected non-compliance,
  • up to PLN 250,000 for omitting importer contact details on labels or IFUs,
  • up to PLN 250,000 for improper transport, storage, or warehousing conditions.

Incorrect labeling, outdated UDI records in EUDAMED, or using obsolete declarations of conformity can be seen as deliberate deception of authorities—carrying administrative consequences.

Operational Responsibilities That Increase Penalty Risk If Neglected

In enforcement contexts, the highest administrative risk stems from flawed compliance systems. Key responsibilities include:

  • timely updates to EUDAMED records,
  • reporting serious incidents to the manufacturer and notified body,
  • maintaining documentation aligned with MDR/IVDR and ISO 13485,
  • monitoring device consistency with labeling and packaging,
  • ensuring end users receive full Polish-language documentation, including current IFU and DoC.

The Person Responsible for Regulatory Compliance (PRRC) is also accountable for overseeing these operational duties.

How Pure Clinical Helps Implement Systematic MDR/IVDR Compliance

Reducing regulatory and financial risks requires implementation of MDR, IVDR, and national law-aligned systems. Pure Clinical offers:

  • review of labels, marketing content, and user documentation for communication risks,
  • implementation of complaint handling and non-compliance reporting procedures,
  • URPL and notified body audit readiness assessments,
  • training for distributors and importers on sanction-related obligations,
  • development and integration of MDR/IVDR and ISO 13485 compliance systems including 2025/1021 Regulation updates.

Through practical expertise and regulatory experience, Pure Clinical helps reduce violations and protect organizations from financial and operational risks.

FAQ

Does every labeling mistake automatically lead to an administrative penalty?

Not necessarily. Authorities evaluate whether the error misleads users or poses a safety risk. Minor technical issues might result in a corrective request rather than a fine, but repeated or intentional violations increase the likelihood of penalties.

Is a marketing agency liable for regulatory violations in device advertisements?

Liability falls primarily on the economic operator promoting the product. Agencies may be held accountable only in cases of contractual responsibility or proven intentional misconduct.

What can a PRRC do to reduce the risk of non-compliance penalties related to user documentation?

The PRRC should implement a structured approval procedure for IFUs, labels, and promotional content within the QMS. Pre-distribution checkpoints and periodic audits of public-facing materials (e.g., websites) are best practices.

Do the new obligations from Regulation 2025/1021 apply immediately upon publication?

No – some requirements, such as the standardized EUDAMED non-conformity format, take effect from 2026. However, early alignment is critical to avoid operational disruptions during future inspections.