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URPL · Europe

Poland medical device regulatory resources

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5 free resources22/25 topics with recordsOct 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.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Poland. Each question separates published rules from details still awaiting verification.

Structured regulatory requirements

Explore all 63 source-linked facts →

22 of 25 research dimensions currently covered · 30 official sources · latest verification 2026-10-21

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
Use the Polish certificate route and its own processing period
For a new free sale certificate, use the official URPL application and identify the product legal regime. Article 30 provides a 15 working day certificate period and requires proof of payme…
Check the export certificate against the new identity
For export, the Member State where the manufacturer or authorised representative has its registered place of business shall issue a free sale certificate upon a qualifying request under MDR…
5 source-linked facts
Checked 2026-10-21
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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
Attach the actual changed legacy notification records
Under the legacy Article 139 route, a KRS entry or REGON change requires the specified copy of the register change application or business register extract. Changed versions of documents pr…
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…
3 source-linked facts
Checked 2026-10-21
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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
Keep the responsible manufacturer and device identity consistent
The label identifies the device name or trade name, the manufacturer’s name, registered trade name or trademark and registered business address, and the EU authorised representative where a…
Preserve the Polish user-language branch after relabelling
For lay user devices, labels, IFU and user interface information are in Polish or the permitted harmonised symbols/recognisable codes; the conformity declaration is in Polish or translated…
5 source-linked facts
Checked 2026-10-21
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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
Open details →
D14

Fees

Unresolved
Free-sale certificate application (Act Art. 30(1))
PLN 700
Clinical-investigation application (MDR Art. 70(1))
PLN 6,000
7 maintained fee lines · 2 related facts
Checked 2026-10-21
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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
Retain the exact legacy-change and lawful-stock conditions
For eligible legacy IVDs, organisational/name/address/legal form or AR changes are generally not significant design/intended purpose changes under MDCG 2022 6. Apply amended Article 110 rat…
Retain the exact legacy-change and lawful-stock conditions
For eligible legacy MDs, administrative name/address/legal form changes are generally not significant design/intended purpose changes. The merger/acquisition example requires continuation o…
3 source-linked facts
Checked 2026-10-21
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Lifecycle & post-market

D17

Change control

Verified
Update the actual economic operator and current EUDAMED records
Manufacturers, authorised representatives and importers register their own actor identity in EUDAMED and obtain an SRN where required. Changes to Annex VI Part A actor information are updat…
Document an authorised-representative switch separately
An authorised representative change must be addressed in an agreement between the manufacturer and, where practicable, outgoing and incoming representatives. It covers termination and start…
8 source-linked facts
Checked 2026-10-21
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D18

UDI, listing & traceability

Verified
Map the actual reference, model and UDI change
A commercial REF, order number or catalogue code must first be mapped to the actual device identifier. Annex VI requires a new UDI DI when a change could cause misidentification or ambiguit…
Map the actual reference, model and UDI change
A commercial REF, order number or catalogue code must first be mapped to the actual device identifier. Annex VI requires a new UDI DI when a change could cause misidentification or ambiguit…
3 source-linked facts
Checked 2026-10-21
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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 2026-10-21

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
Other clinical investigation application (Act Art. 33(3); MDR Art. 82(1))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))

MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock

Elapsed time is Eudamed actor and device registration, which has no guaranteed processing time, plus any national registration duty

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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