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Does my medical device need BfArM DiGA listing per DiGAV in Germany?

Describe your device to check whether BfArM DiGA listing per DiGAV 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 BfArM DiGA listing per DiGAV check is screening

Checks listed products such as syringes, needles, gloves, condoms, implants, IUDs, and blood bags. Applies when the product, feature, component, or use is in scope.

Requirement family: Product-specific compulsory conformity
Regulatory object: digital health application
Maintained rule status: mandatory if feature
Useful product facts: Exact product category, sterile/single-use status, materials, variants, and applicable product standard.

Conformity assessment for conventional devices is EU-level (MDR Annexes IX-XI; no national testing/certification overlay found in MPDG Kapitel 2-3 or MPBetreibV 2025). DiGA — CE-marked class I/IIa digital medical devices — must additionally satisfy the DiGAV requirements (data protection and data security, quality, interoperability) as part of the BfArM listing procedure.

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 Germany routes to check

Check every Germany route →

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.

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 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 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.