Device Classification and Registration
Device Classification:
Devices are classified into four risk-based classes (I, IIa, IIb, III), consistent with EU rules. Classification is determined by intended use, invasiveness, and other risk factors, with the manufacturer responsible for initial classification and URPL resolving disputes.
Registration and Market Entry:
Documentation: Manufacturers must prepare comprehensive technical files in Polish, including device description, clinical data, risk assessment, and labeling.
Conformity Assessment:
-Class I: Self-assessment by manufacturer.
-Classes IIa, IIb, III: Notified Body review and certification (valid for five years).
-Declaration of Conformity: Required after successful assessment.
-Authorized Representative: Non-EU manufacturers must appoint an EU-based representative.
-Application Submission: Submit in Polish (triplicate and electronic), with all documentation and proof of fee payment. Online registration is available since July 2023.
-CE Marking: Affix CE mark after conformity assessment; higher classes require the Notified Body’s number. Notify the Register for certain device types after first use in Poland.
Labeling and Instructions:
-All labeling and instructions must be in Polish; harmonized symbols may supplement or replace text.
-English labeling is allowed only for devices supplied directly to healthcare professionals (with consent); patient-facing information must always be in Polish.
-CE mark and Notified Body number (if applicable) must be visible.
Obligations for Manufacturers, Importers, and Distributors:
-Authorized Representative: Required for foreign manufacturers.
-Record Keeping: Maintain detailed records of suppliers and distributors.
-Clinical Trials: Required for most new devices unless exempted by URPL; must document benefit/risk and side effects.
-Corrective Actions: Manufacturers must update instructions, modify, or recall devices if risks are identified post-market.
Quality Management System (QMS):
-ISO 13485 Certification: Mandatory for all manufacturers.
-Audits: Required for higher-class devices by a Notified Body.
-Documentation: Maintain up-to-date technical and QMS records.
Adverse Event Reporting and Surveillance:
-Report serious adverse events to URPL within 15 days.
-Implement corrective actions promptly, including recalls or updates.
-Ongoing surveillance and regular safety reports are required.
Requirements and Enforcement:
-Since July 2023, online registration is mandatory for distributors, users, and custom-made device importers.
-Non-compliance can result in penalties up to PLN 200,000.
-URPL may inspect, review documentation, and seize or destroy non-compliant products.
-Market access and reimbursement are available through public and private healthcare providers, with some devices requiring health technology assessment and price negotiations.
Practical Advice:
-Engage early with URPL especially for classification.
-Ensure all documentation and labeling are accurately translated into Polish.
-Stay updated on regulatory changes and maintain reliable local representation if based outside of EU.
Summary Table of Key Steps
| Step | Requirement |
|---|---|
| Classification | Manufacturer classifies; URPL resolves disputes |
| Documentation | In Polish, includes risk, clinical, labeling, QMS |
| Conformity Assessment | Notified Body for Ila/lib/III; self-assessment for I |
| Application Submission | In Polish, triplicate + electronic, with fee |
| CE Marking | Affix after approval; Notified Body number for higher |
| Labeling | Polish language; harmonized symbols; exceptions for pros |
| Adverse Event Reporting | To URPL within 15 days; implement corrective actions |
| Clinical Trials | Required unless exempt; URPL supervision |
| Post-Market Surveillance | Ongoing, annual safety reports |
| Online Registration | Mandatory since 2023 |
| Penalties | Up to PLN 200,000 for non-compliance |
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