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Does my medical device need D.Lgs. 128/2016 radio equipment market access in Italy?

Describe your device to check whether D.Lgs. 128/2016 radio equipment market access may apply, why, what facts are missing, and which official source to review.

8 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 D.Lgs. 128/2016 radio equipment market access check is screening

Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. Applies when the product, feature, component, or use is in scope.

Requirement family: Radio and spectrum approval
Regulatory object: radio equipment
Maintained rule status: mandatory if feature
Useful product facts: Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.

Article 6 of decreto legislativo 22 June 2016 n. 128 permits making available on the market only radio equipment that complies with the decree, and article 39 makes the Ministry the market surveillance authority. Article 7 permits putting into service and use of compliant equipment that is properly installed, maintained and used for its purpose, and allows the Ministry to add requirements only for more effective spectrum use, to avoid harmful interference or electromagnetic disturbance, or on public-health grounds — so there is no Italian product type approval. The decree names the Ministero dello sviluppo economico, now the Ministero delle imprese e del made in Italy.

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 Italy routes to check

Check every Italy 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.

Environmental / battery

D.Lgs. 27/2014 substance restriction (RoHS)

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

Environmental / battery

Registro AEE registration as a precondition for market placement

Maintained as a mandatory pre-market route.

Environmental / battery

Registro dei produttori di batterie

Maintained as a mandatory pre-market route.

Radiation

Notifica di pratica for radiation practices

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

Radiation

Nulla osta preventivo (category A or B)

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

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.

Normattiva

D.Lgs. 128/2016 art. 6 — making radio equipment available on the market

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 Italy 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 Italy?: 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.