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 Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device in Iceland?
Describe your device to check whether Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device 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 Reglugerð nr. 303/2018 um rafsegulsamhæfi — EMC carried inside the MDR route for a medical device check is screening
Distinguishes medical EMC evidence from a separate conformity or supplier-declaration route. Evidence is normally handled inside the medical-device registration route.
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
- Electromagnetic compatibility
- Regulatory object
- electrical medical equipment
- Maintained rule status
- included in medical registration
- Useful product facts
- Active electronics, emissions, immunity, radio functions, and existing EMC reports.
Reglugerð nr. 303/2018 um rafsegulsamhæfi transposes Directive 2014/30/EU into Icelandic law — 26. gr. names the directive and EEA Joint Committee Decision No 46/2016 — and 13. gr. makes CE marking a condition of placing equipment on the market in Iceland, with the manufacturer obliged to affix a visible, legible and indelible mark. Article 1, fourth paragraph, switches the regulation off for equipment where another specific instrument lays the same essential requirements down more precisely, which is what MDR Annex I sections 18.5 and 18.6 do for a medical device, so for a device the EMC evidence sits in the MDR technical file and no separate Icelandic EMC certificate is issued. 18. gr. gives market surveillance to Mannvirkjastofnun, whose functions now sit in the Húsnæðis-, mannvirkja- og skipulagsstofnun (HMS); for equipment that is not a medical device the regulation applies directly. The regulation took effect on 24 March 2018 and repealed reglugerðir nr. 397/2012 and nr. 786/2014.
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
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
Radiation
Geislavarnir ríkisins licence for ionizing-radiation sources and radiation devices
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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