Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksGermany medical device certification and licence checker
Check Germany requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
10 maintained routes13 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.
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
Medical device certification routes in Germany
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
Wireless / radio
Funkanlagengesetz (RED) conformity
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Environmental / battery
ElektroStoffV substance restriction (RoHS)
Evidence may be required, but the matrix does not identify a generic separate certificate.
Source association awaiting review
Environmental / battery
ElektroG producer registration with stiftung ear
Maintained as a mandatory pre-market route.
Source association awaiting review
Environmental / battery
BattDG battery producer registration
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Radiation
StrlSchG licence or notification for operating X-ray equipment
Applies to the facility, operator, or installation rather than only the product.
Source association awaiting review
Metrology
MPBetreibV metrological controls
Applies to the facility, operator, or installation rather than only the product.
Source association awaiting review
Electrical safety
MPBetreibV safety-technical controls
Applies to the facility, operator, or installation rather than only the product.
Source association awaiting review
Product-specific
BfArM DiGA listing per DiGAV
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
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
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
Gesetze im Internet (Bundesamt für Justiz)
Funkanlagengesetz § 4 — essential requirements for radio equipment
Gesetze im Internet (Bundesamt für Justiz)
ElektroStoffV § 3 — RoHS placing-on-market conditions and EU declaration of conformity
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
Gesetze im Internet (Bundesamt für Justiz)
ElektroG § 6 — producer registration before placing electrical equipment on the market
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
Gesetze im Internet (Bundesamt für Justiz)
BattDG § 4 — supply prohibition without registration under Article 55 of Regulation (EU) 2023/1542
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
Gesetze im Internet (Bundesamt für Justiz)
StrlSchG §§ 12 and 19 — licence and notification duties for operating X-ray equipment
Gesetze im Internet (Bundesamt für Justiz)
MPBetreibV § 15 and Anlage 2 — metrological controls and re-test intervals
Gesetze im Internet (Bundesamt für Justiz)
MPBetreibV § 12 — safety-technical controls on Anlage 1 products
BfArM
DiGA Wissenswertes — DiGAV requirements in the BfArM listing procedure
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 Germany 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 Germany?
- 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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