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Does my medical device need Sąvadas registration one working day before first supply in Lithuania?

Describe your device to check whether Sąvadas registration one working day before first supply may apply, why, what facts are missing, and which official source to review.

7 maintained routes8 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 Sąvadas registration one working day before first supply check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Maintained as a mandatory pre-market route.

Requirement family: Environmental and battery obligations
Regulatory object: producer or authorised representative
Maintained rule status: mandatory pre market
Useful product facts: Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

Point 1 of the producer and importer registration rules approved by order of the Minister of Environment D1-291 of 27 May 2009, consolidated to amendment D1-151 of 13 August 2026, governs registration in the producers and importers register for those supplying batteries, electrical and electronic equipment and other listed products to the Lithuanian internal market, and point 5 requires registration no later than one working day before the products are first supplied. The register is operated by the Aplinkos apsaugos agentūra within the GPAIS system. The substantive extended-producer-responsibility articles of the waste management act VIII-787 were not separately opened. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

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 Lithuania routes to check

Check every Lithuania 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

RRT radio equipment technical regulation

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

Environmental / battery

Order 4-459 RoHS market surveillance rules

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

Environmental / battery

Sąvadas extended to serve as the Article 55 battery register

Maintained as a mandatory pre-market route.

Metrology

VASPVT technical-condition inspection permits

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.

Lietuvos Respublikos Seimas (e-seimas)

Order D1-291 producer and importer registration rules, consolidated — Sąvadas and the pre-supply deadline

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 Lithuania 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 Lithuania?: 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.