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Does my medical device need Prawo atomowe zezwolenie for radiation activity in Poland?

Describe your device to check whether Prawo atomowe zezwolenie for radiation activity may apply, why, what facts are missing, and which official source to review.

7 maintained routes11 official source links

Preliminary applicability · country-specific scope

What you receive

Not just a yes or no

A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.

Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.

Official starting points. Open the regulator or government sources behind the maintained country matrix.

Maintained country rule

What this Prawo atomowe zezwolenie for radiation activity check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

Requirement family: Ionizing radiation and radioactive sources
Regulatory object: radiation device manufacture trade or use
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Prawo atomowe art. 4(1) makes a licence (zezwolenie) or, where the act allows, a notification mandatory for producing, installing, using or servicing devices containing radioactive sources and for trading in those devices (pt 9); for commissioning or using devices generating ionising radiation (pt 10); for commissioning laboratories where ionising radiation sources are to be used, in particular X-ray and medical X-ray laboratories (pt 11); for the intentional addition of radioactive substances when manufacturing medical devices, medical device accessories, Annex XVI products and IVDs within the meaning of Regulations (EU) 2017/745 and 2017/746 (pt 12(b)); and for trading in those products (pt 13). Art. 4(4) transfers licensing of medical X-ray apparatus and medical X-ray laboratories to the state voivodeship sanitary inspector, and art. 33q adds a separate zgoda for radiotherapy and nuclear medicine units.

How to read the answer

Classification is only the first layer

A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

Dossier or import evidence

Testing can belong inside the medical dossier, while some documents apply to each shipment.

Site or operator licence

Radiation, installation, use, or measurement controls may apply to a facility or operator.

Country-specific scope

Other Poland routes to check

Check every Poland route →

Electrical safety

MDR electrical safety in place of the Low Voltage Directive

Evidence is normally handled inside the medical-device registration route.

EMC

MDR electromagnetic compatibility in place of the EMC Directive

Evidence is normally handled inside the medical-device registration route.

Wireless / radio

Radio equipment conformity assessment under Dz.U. 2016 poz. 878

Applies when the product, feature, component, or use is in scope.

Environmental / battery

RoHS essential requirements under Dz.U. 2021 poz. 1513

Evidence may be required, but the matrix does not identify a generic separate certificate.

Environmental / battery

BDO register entry before starting the activity

Maintained as a mandatory pre-market route.

Environmental / battery

Battery producers in the same BDO register

Maintained as a mandatory pre-market route.

Official starting points

Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.

ELI Poland (Kancelaria Prezesa Rady Ministrów)

consolidated Prawo atomowe — licence, registration and notification duties

About this checker

A preliminary tool, not a regulatory determination

Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Poland scheme matrix and links each route to its official source.

Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.

Is this the same as medical device classification in Poland?: No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
Does “no separate certificate” mean no testing is required?: No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
Is the result an official regulatory determination?: No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.