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

The URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych) is the central government administration authority in Poland. It is responsible for the oversight of medical devices, ensuring they meet the safety and efficacy standards required by both Polish and European law.

Key Roles and Responsibilities

The Office performs several critical functions to protect public health:

• Registration and Notification: It manages the official registers and processes notifications for medical devices placed on the market or put into service within Poland.
• Supervision of Medical Incidents: Through its Materiovigilance system, URPL monitors and analyzes reports of adverse incidents to prevent recurrence and ensure patient safety.
• Clinical Trials: The President of the Office issues decisions granting permission for clinical trials of medical devices and supervises their conduct to ensure ethical and scientific standards.
• Market Surveillance: URPL conducts inspections and surveillance of devices manufactured or marketed in Poland to verify ongoing compliance with technical and safety requirements.
• Classification and Qualification: It resolves disputes regarding the classification of medical devices and their accessories.
• Certificates of Free Sale: Issues certificates to Polish manufacturers to facilitate the export of their products to non-EU countries.

Regulatory Framework

URPL implements the following key European regulations:

• Medical Device Regulation (MDR) 2017/745
• In Vitro Diagnostic Regulation (IVDR) 2017/746