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 Loi du 27 juin 2016 on making radio equipment available in Luxembourg?
Describe your device to check whether Loi du 27 juin 2016 on making radio equipment available may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 candidate 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 Loi du 27 juin 2016 on making radio equipment available 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.
Source association awaiting review. These are unreviewed candidate links retained from legacy data. They must not be cited as proof that this route or requirement applies.
- 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 7 of the loi modifiée of 27 June 2016 has the ILNAS market surveillance department authorise the putting into service and use of radio equipment that complies with the law when properly installed, maintained and used for its purpose, and article 9(1) provides that making compliant radio equipment available on the market may not be obstructed on grounds covered by the law. That free-movement clause is an express negative: no Luxembourg type approval appears anywhere in the text. ILR supplies the regulated radio interfaces that ILNAS notifies, and spectrum authorisations run under the loi modifiée of 30 May 2005. The consolidated text read is the version as at 27 December 2019; the loi of 3 March 2026 transposing Directive (EU) 2024/2839 has since amended it, so article numbering may have moved.
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 Luxembourg routes to check
Electrical safety
MDR electrical safety in place of the Low Voltage Directive
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
MDR electromagnetic compatibility in place of the EMC Directive
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Environmental / battery
Règlement grand-ducal du 30 juillet 2013 substance restriction (RoHS)
Evidence may be required, but the matrix does not identify a generic separate certificate.
No supporting source association
Environmental / battery
Registre des producteurs for electrical and electronic equipment
Applies when the product, feature, component, or use is in scope.
No supporting source association
Environmental / battery
Batteries Regulation producer register pending a national act
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Radiation
Division de la radioprotection establishment authorisation
Applies to the facility, operator, or installation rather than only the product.
Source association awaiting review
Radiation
Acceptance test and conformity finding before use
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Candidate sources awaiting review
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 Luxembourg 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 Luxembourg?
- 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?
Keep researching this market
More Luxembourg medical device resources
Continue with this market