URPL market access

Poland medical device registration resources

Research URPL registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Poland medical device resource.

3 free resourcesAug 2026 fees reviewed

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Everything we track for Poland

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Medical device regulation news

Follow recent Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary URPL risk class with official rule references.

Government registration fees

Review current URPL application, review, and renewal fees.

Government fees

Full fee schedule (7 lines) →

URPL registration fees in PLN · reviewed 2026-08-25

Fee line	Amount	Provenance
Free-sale certificate application (Act Art. 30(1))	PLN 700	Verified
Clinical-investigation application (MDR Art. 70(1))	PLN 6,000	Verified
Substantial modification notification (MDR Art. 75(1))	PLN 2,000	Verified
Post-market clinical follow-up investigation application (Act Art. 33(3))	PLN 6,000	Verified

3 more fee lines on the full schedule · 7 of 7 rows source-verified

Latest regulation news

All Poland regulation news →

Newest URPL-related headlines from the daily-refreshed feed — every row links to the publishing source.

Aug 26MGMedEnvoy GlobalWhat Is a Saudi Arabia Authorized Representative for Medical Devices?

Poland Aug 26OSOperon StrategistSFDA Medical Device Establishment License (MDEL): Complete Compliance Guide

Poland Aug 25MGMedEnvoy GlobalHow Does Mexico Classify Single-Use Versus Reusable Medical Devices?

Poland Aug 25FLFDA Law BlogFDA Addresses Device Constituents in New Draft Guidance on Container Closure Systems

Poland Aug 25PBPacific BridgeCan Foreign Clinical Data be Used to Get Your Medical Device Approved in Japan?

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Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Poland work.

Poland market-launch workpaper

Connect the URPL route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Poland dossier reuse and delta

Compare an existing authorization and evidence set against URPL administrative, testing, labeling, and dossier needs.

Poland change notification workpaper

Map a product or manufacturing change to URPL evidence, notification, timing, and implementation questions.

Poland regulatory change impact

Assess a current URPL update against one product and turn it into an owner-ready action workpaper.

Poland cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Poland (URPL).

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