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Does my medical device need ANMDMR in-use verification tests in Romania?

Describe your device to check whether ANMDMR in-use verification tests may apply, why, what facts are missing, and which official source to review.

1 maintained routes2 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 ANMDMR in-use verification tests check is screening

Checks whether electrical safety is dossier evidence or a separate national product certificate. Applies to the facility, operator, or installation rather than only the product.

Requirement family: Medical electrical safety
Regulatory object: electromedical device in use
Maintained rule status: mandatory for use site
Useful product facts: Power source, voltage, intended environment, patient connection, device type, and IEC/CB evidence.

Ordin 3467/2022 Annex 1 items 6.1-6.12 charge in-use verification: electrosecurity tests for electromedical devices 250 lei, performance tests 180 lei, CNCAN acceptability-criteria tests 1,000 lei, CNCAN use authorisation/re-authorisation 30% of base tariff, use-authorisation issuance 20 lei. Periodic in-use verification scope and periodicity are set in Annex 1 to Ordin 2219/2022; health units must keep a designated responsible person and a register of devices in use (Art. 20); devices failing the tests may not be used (Art. 21(1); Legea 95/2006 arts. 931-933).

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 Romania routes to check

Check every Romania 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.

ANMDMR

Ordin 3467/2022 Annex 1 — in-use device verification test fees including CNCAN

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 Romania 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 Romania?: 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.