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Does my medical device need Nulla osta preventivo (category A or B) in Italy?

Describe your device to check whether Nulla osta preventivo (category A or B) 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 Nulla osta preventivo (category A or B) check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

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

D.Lgs. 101/2020 art. 50 makes a prior nulla osta mandatory for practices using generators whose accelerated particles exceed 200 keV, neutron sources above 1e4/s, radioactive materials above the Annex XIV multiples, and separately for intentional addition of radioactive materials to consumer products, industrial radiography and product treatment, deliberate administration of radioactive materials for medical or veterinary diagnosis, therapy or research, therapeutic exposure with accelerators or generators, high-activity sealed sources, and mobile medical radiodiagnostic X-ray use at 200 keV or more. The nulla osta covers site approval, commissioning tests of the protection systems, radioactive effluent disposal programmes and access control, and practices are classified into categories A and B.

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.

Wireless / radio

D.Lgs. 128/2016 radio equipment market access

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

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.

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 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.