Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Geislavarnir ríkisins licence for ionizing-radiation sources and radiation devices in Iceland?
Describe your device to check whether Geislavarnir ríkisins licence for ionizing-radiation sources and radiation devices may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 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 Geislavarnir ríkisins licence for ionizing-radiation sources and radiation devices check is screening
Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.
Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.
- Requirement family
- Ionizing radiation and radioactive sources
- Regulatory object
- ionizing radiation sources and radiation devices
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
Lög nr. 44/2002 um geislavarnir Article 7 makes the production, import, export, possession, storage, delivery, use, recycling, recovery and disposal of radioactive substances subject to a licence from Geislavarnir ríkisins, and its later paragraph adds that the use of notification-triggered radiation devices emitting ionizing radiation is likewise 'háð leyfi Geislavarna ríkisins' — import of such a device is only notifiable. An X-ray, CT or accelerator-based medical device therefore needs an Icelandic licence for its use in Iceland even though it contains no radioactive source, and the licence is a use-site obligation that sits outside the MDR conformity route. Article 19 requires the licence holder to pay for regular inspection and licence assessment on a tariff the minister sets on the institution's proposal, and Article 21 covers the tariff for the institution's service measurements.
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.
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 Iceland routes to check
Electrical safety
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
Fjarskiptastofa radio-equipment market access (reglugerð nr. 944/2019)
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Metrology
HMS legal-metrology conformity assessment and verification (lög nr. 91/2006)
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Environmental / battery
Producer responsibility and the úrvinnslugjald as a condition of placing electrical and electronic equipment on the Icelandic market
Maintained as a mandatory pre-market route.
Source association reviewed
Reviewed source associations
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.
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 Iceland scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
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 Iceland?
- 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.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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