Medical Device Regulation in Poland
Poland, as an EU member state, applies the EU Medical Device Regulation (EU MDR 2017/745) for the regulation of medical devices. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB) serves as the national competent authority. Poland is one of the largest medical device markets in Central and Eastern Europe.
Recent Regulatory Updates
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EUDAMED SRN registration becomes mandatory May 28.
EUDAMED 4 modules mandatory from May 2026
New EURL designation calls for 8 IVD categories
Sources Tracked by Qalico
Qalico continuously monitors 2 references across guidelines, regulations, and standards for Poland.
Guidelines
Device Classification
Poland follows the EU MDR classification system based on Annex VIII rules. Class I devices are low risk (e.g., stethoscopes, hospital beds). Class IIa devices are low-medium risk (e.g., dental crowns, hearing aids). Class IIb devices are medium-high risk (e.g., lung ventilators, bone fixation plates). Class III devices are the highest risk (e.g., coronary stents, breast implants).
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- CE marking under EU MDR 2017/745 is mandatory for all devices on the Polish market.
- Economic operators must register in the Polish national device database maintained by URPLWMiPB.
- Polish language labeling and instructions for use are required.
- The 2022 Polish Act on Medical Devices provides national implementing provisions for the EU MDR.
- Clinical investigations require authorization from URPLWMiPB and a bioethics committee.
Pre-Market Requirements
Manufacturers must complete conformity assessment procedures as specified in the EU MDR. Notified Body involvement is required for Class IIa, IIb, and III devices.
CE marking is required before placing any medical device on the Polish market.
Manufacturers, authorized representatives, and importers must register with URPLWMiPB and notify the authority of devices placed on the Polish market.
Complete technical documentation in line with EU MDR Annexes II and III must be prepared and maintained, available for review by authorities.
Post-Market Requirements
A proactive PMS system must be maintained by manufacturers, proportionate to the risk class of the device.
Serious incidents and field safety corrective actions must be reported to URPLWMiPB per EU MDR vigilance requirements.
PSURs must be submitted for Class IIa, IIb, and III devices, providing a systematic review of PMS data.
URPLWMiPB conducts market surveillance activities including inspections and product testing to ensure ongoing compliance.
International Recognition & Reliance
As an EU member state, Poland fully applies the EU MDR and recognizes CE-marked devices from any EU-designated Notified Body.