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Does my medical device need ANVS registratie for trade storage and lower-risk devices in Netherlands?

Describe your device to check whether ANVS registratie for trade storage and lower-risk devices 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 ANVS registratie for trade storage and lower-risk devices 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: device storage for trade or distribution
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Where the licence duty does not apply, art. 3.9 and art. 3.10(2) impose ANVS registration. Art. 3.10(2)(b) registers holding a toestel or versneller purely in storage for trade, distribution and installing or removing it without operating it under high voltage, which is the ordinary position of a distributor. Art. 3.10(2)(d) and (e) register veterinary diagnostic devices with a fixed downward beam and fixed-location dental diagnostic devices other than cone-beam CT, and (f) devices used in population screening.

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 Netherlands routes to check

Check every Netherlands 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

Besluit radioapparaten 2016 conformity

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

Environmental / battery

Regeling gevaarlijke stoffen in elektrische en elektronische apparatuur (RoHS)

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

Environmental / battery

Nationaal (W)EEE Register producer registration

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

Environmental / battery

Batteries Regulation producer register announced but not yet operating

A transition is identified; the applicable date and current status must be checked.

Radiation

ANVS vergunning for devices and accelerators

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.

EUR-Lex

Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

Rijkswaterstaat (Afvalcirculair)

extended producer responsibility for batteries — register under construction and applications on hold

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 Netherlands 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 Netherlands?: 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.