URPL · Europe

Poland medical device regulatory resources

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5 free resources23/25 topics with recordsAug 2026 fees reviewed

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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.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Poland requirements.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 46 source-linked facts →

23 of 25 research dimensions currently covered · 21 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Prezes URPL) is the Polish competent authority for medical devices and IVDs (MDR Art.…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation act: Act of 7 April 2022 on medical devices (Ustawa o wyrobach medycznych, consolidated text Dz.U. 2024 poz. 1620) implements MDR and IVDR in Poland: it sets obligations of economic operators, h…

1 source-linked fact

Checked 2026-08-25

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D03

Device definition & scope

Verified

National scope beyond the EU regulations: Beyond implementing MDR/IVDR, the Act governs the use and maintenance of devices (including MDR Annex XVI products and IVDR Art. 1(2) products), clinical investigation and performance study…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

EU MDR classes I, Is, Im, Ir, IIa, IIb and III: Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

1 maintained scheme · 1 related fact

Checked 2026-08-26

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D05

Registration pathways

Verified

Free sale certificate: URPL issues free sale certificates (MDR Art. 60 / IVDR Art. 55) at the request of a manufacturer or authorised representative established in Poland, within 15 working days of application; t…
Transitional continuation of old-law notifications: Notifications made under the repealed 2010 Act continue under the old rules until EUDAMED registration becomes mandatory for the given entity (MDR Art. 123(3)(d)/IVDR Art. 113(3)(f)), with…

3 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

NMPA certificate does not replace EU conformity assessment: statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce…
EU CE under MDR/IVDR — single market validity: target: geo:pol · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

2 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Custom-made device producer registration: A producer of custom made devices, the authorised representative of a foreign custom device producer, and a custom device importer, each established in Poland, must apply to the President o…
Foreign operators acting through a Polish branch: Importer and distributor obligations apply to a foreign entrepreneur conducting business in Poland through a branch within the meaning of the 2018 Act on participation of foreign entreprene…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

National distributor register (Art. 21): Distributors established in Poland who first make a device, system or procedure pack available on Polish territory must obtain access credentials to URPL's distributor register and, for eac…
Ban on importing non-compliant devices: Importing into Poland devices that do not meet MDR/IVDR requirements (or systems and procedure packs containing them) for use in Poland is prohibited; import for strictly personal use is pe…

4 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Language of documents requested by the authority: Information and documents requested by URPL from manufacturers or authorised representatives (MDR Art. 10(14)/11(3), IVDR Art. 10(13)/11(3)) must be submitted in Polish or English; URPL may…
Documents for SRN application by a foreign manufacturer: A foreign manufacturer's SRN application must attach: a registry extract not older than 3 months, legalised by a Polish consul or apostilled; where the extract does not show the representin…

2 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

National submission surfaces beyond EUDAMED: Beyond EUDAMED, URPL operates national surfaces: SRN applications on Forms 1 4 with filling instructions; the distributor register at d.urpl.gov.pl; the healthcare provider import register…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Polish language requirement for lay-user devices: Devices, systems and procedure packs intended for lay users must carry labels, instructions for use and a user interface in Polish, or expressed through harmonised symbols or recognisable c…
Language rules for professional devices: Devices intended for professional users must carry the EU declaration of conformity (or Art. 22 statements), labels and IFU in Polish or English; information addressed to the patient must b…

2 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Unresolved

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Radio equipment conformity assessment under Dz.U. 2016 poz. 878: Wireless / radio

7 maintained overlays

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D14

Fees

Verified

Free-sale certificate application (Act Art. 30(1)): PLN 700
Clinical-investigation application (MDR Art. 70(1)): PLN 6,000

7 maintained fee lines · 1 related fact

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Certificate validity and renewal (Art. 56(2)): EU certificates issued by notified bodies are valid for the period they indicate, which may not exceed five years. On application by the manufacturer the validity of the certificate may be…

1 source-linked fact

Checked 2026-08-29

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Lifecycle & post-market

D17

Change control

Verified

Legacy notification change reporting until 2031: Until 1 January 2031, entities that made notifications under the repealed 2010 Act must report changes of data (manufacturer/AR name and address, device trade name, notified body number) to…
7-day duty to report changes to national registers: Entities entered in the distributor register, the import/user register or the custom producer register must inform the President of URPL within 7 days of any change of name or address (not…

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Duty of healthcare institutions to store UDI codes: Public health institutions and other professional or business users of devices must retain and store, in electronic form, the UDI codes of devices, systems and procedure packs supplied to t…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Language of clinical investigation submissions: Clinical investigation applications (MDR Art. 70(1)) and related notifications to URPL are made in Polish or English, except participant facing information and documents and the investigati…
Bioethics opinion as a precondition with a 45-day deadline: A URPL clinical investigation permit may be issued only after a positive opinion of a bioethics committee (or the Appeal Bioethics Committee); the committee must issue its opinion within 45…

4 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Import of investigational devices: Investigational devices, non CE marked devices and medicinal products without marketing authorisation may be imported into Poland in the quantity necessary for a clinical investigation or p…
National permit for devices without conformity assessment: The President of URPL may grant, by administrative decision, a permit to place on the market or put into use in Poland a specific device that has not undergone conformity assessment procedu…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market surveillance reporting (Arts. 83-86): Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

1 source-linked fact

Checked 2026-08-29

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D22

Vigilance & incident reporting

Verified

Duty of professionals to report serious incidents to the manufacturer and URPL: Professional users, healthcare providers, diagnostic laboratories, importers, distributors and repair/service/maintenance/calibration entities that establish a serious incident in the cours…
National reporting channel and language for serious incidents: Manufacturers' serious incident reports and explanatory statements (MDR Art. 87 88, IVDR Art. 82 83) are directed to the President of URPL as the competent authority for incidents occurring…

4 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Operator duty to warn users; URPL substitute action: An economic operator that placed on the market, put into use or imported a device must notify users of threats related to devices, systems or procedure packs in a manner adequate to the thr…
URPL withdrawal and restriction decisions: Where a device presents a risk (MDR Art. 95(4)/IVDR Art. 90(4)) or in the safeguard situations (MDR Art. 97(2), 98(1)/IVDR Art. 92(2), 93(1)), the President of URPL issues an administrative…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Mandatory warning in public advertising: Advertising directed at the public must include the warning: 'To jest wyrób medyczny. Używaj go zgodnie z instrukcją używania lub etykietą.' (This is a medical device. Use it according to t…
Only economic operators may advertise devices; information vs advertising: Only an economic operator whose activity covers manufacturing, import, distribution or placing on the market of the advertised device may advertise devices; drawing up summaries of device c…

4 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal against a bioethics commission opinion: An appeal from an opinion (opinia) of a bioethics commission lies to the Appellate Bioethics Commission (Odwoławcza Komisja Bioetyczna) at the Minister of Health.
Clinical investigation permit refusal: reasoned decision and appeal clock: A refusal of a clinical investigation application (or an application under Art. 29 30) is issued as a decision; the factual and legal justification is drawn up within 30 days of the decisio…

2 source-linked facts

Checked 2026-08-25

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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

Registration timeline

Full registration timeline →

Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification