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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.

5 free resources24/25 requirements coveredAug 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 45 source-linked facts →

24 of 25 research dimensions currently covered · 19 official sources · latest verification 2026-08-30

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
National SRN application after EUDAMED registration
After submitting registration data to EUDAMED (MDR Art. 31(1)/IVDR Art. 28(1)), a manufacturer or importer established in Poland — and a foreign manufacturer whose authorised representative…
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
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…
1 source-linked fact
Checked 2026-08-30
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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…
Register of devices imported by healthcare providers and professional users (Art. 22)
Healthcare providers and other professional or business users who import a device, system or procedure pack into Poland for use there must obtain access to URPL's information system and ent…
4 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
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…
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…
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

Verified
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
Checked 2026-08-29
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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
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…
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…
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
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…
National permit also required for PMCF investigations
A sponsor intending to conduct a post market clinical follow up investigation in Poland (MDR Art. 82(1)) must apply to the President of URPL for a permit; the application follows the MDR Ar…
4 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
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…
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…
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
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…
Official serious incident report form (ZIM)
Serious incident reports to URPL use the official report form template (formularz ZIM) laid down by the Minister of Health regulation of 12 December 2022 (Dz.U. 2022 poz. 2682); URPL publis…
4 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
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…
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…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Public advertising restrictions (image of medical professionals, prescription-only devices)
Advertising a device available only on prescription or a device reimbursed under national health insurance in mass media, in generally accessible places or by means of distance communicatio…
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
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…
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.
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 lineAmountProvenance
Free-sale certificate application (Act Art. 30(1))PLN 700Verified
Clinical-investigation application (MDR Art. 70(1))PLN 6,000Verified
Substantial modification notification (MDR Art. 75(1))PLN 2,000Verified
Post-market clinical follow-up investigation application (Act Art. 33(3))PLN 6,000Verified
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

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Poland regulation news →

Newest official URPL headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 5OFOffice for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)Communication of the President of the Office of 5 August 2026 on the Qualification and Classification of Safety Wristbands Used in Telecare Services and the Rules for Recognizing Such Products as Medical Devices and Their Classification under Regulation (EU) 2017/745Poland
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Poland change notification workpaper

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Poland regulatory change impact

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Poland cybersecurity evidence review

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