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Does my medical device need RoHS transposition at ΦΕΚ Α΄ 147/2013 in Greece?

Describe your device to check whether RoHS transposition at ΦΕΚ Α΄ 147/2013 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 RoHS transposition at ΦΕΚ Α΄ 147/2013 check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family: Environmental and battery obligations
Regulatory object: electrical electronic medical device
Maintained rule status: evidence only no separate certificate
Useful product facts: Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

Greece transposed Directive 2011/65/EU by presidential decree published at ΦΕΚ Α΄ 147 of 17 June 2013, pages 2209 to 2224, as recorded on the EUR-Lex national implementing measures page. The gazette citation is confirmed but the decree number is not: the EUR-Lex entry omits it, secondary sources give Π.Δ. 114/2013, and neither et.gr nor the ministry site could be reached to confirm, so the number should not be relied on. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

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

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.

Radiation

EEAE graded radiation practice control

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

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.

The maintained country source registry does not yet map a direct authority page to this exact route. The checker will not substitute an unrelated source. Confirm the current scope with the responsible authority before relying on the result.

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.