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Does my medical device need EEAE graded radiation practice control in Greece?

Describe your device to check whether EEAE graded radiation practice control may apply, why, what facts are missing, and which official source to review.

8 maintained routes10 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 EEAE graded radiation practice control check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.

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

π.δ. 101/2018 (ΦΕΚ 194/Α/20.11.2018) Chapter E section 2, specified by κ.υ.α. 45872/2019 (ΦΕΚ 1103/Β) as amended by κ.υ.α. 32083/2022, sorts radiation practices into three tiers: notification (Annex I part A), registration (part B) and licensing (part C), each closing with an administrative act — a notification number, a registration certificate or a licence. Licensed practices under Annex I part C points 1-6 and 9 must submit the source inventory, an in-force άδεια σκοπιμότητας (justification licence) where medical exposures are involved, the classified worker list and medical physics experts, and a radiation protection expert report with shielding study and dosimetry programme (κ.υ.α. 45872/2019 arts. 19-24).

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 Greece routes to check

Check every Greece 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

Presidential Decree 98/2017 radio equipment market access

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

Environmental / battery

RoHS transposition at ΦΕΚ Α΄ 147/2013

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

Environmental / battery

Producer registry number as a condition of supply

Maintained as a mandatory pre-market route.

Environmental / battery

No Greek Article 55 designation identified

A transition is identified; the applicable date and current status must be checked.

Laser / UV / ultrasound

EEAE MRI laboratory special operating licence

Applies to the facility, operator, or installation rather than only the product.

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.

EEAE

ionising radiation regulatory control — notification, registration and licensing tiers

EEAE

licensing procedure and documents for radiation generators, accelerators and radioactive sources

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 Greece 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 Greece?: 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.