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Does my medical device need Nařízení vlády 426/2016 radio equipment conformity in Czech Republic?

Describe your device to check whether Nařízení vlády 426/2016 radio equipment conformity may apply, why, what facts are missing, and which official source to review.

7 maintained routes10 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 Nařízení vlády 426/2016 radio equipment conformity 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.

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.

§1(1) of nařízení vlády 426/2016 Sb., in the version in force from 28 April 2026, transposes Directive 2014/53/EU and sets the technical requirements radio equipment must meet on being placed on the market or put into service, together with the conditions for making it available and the conformity-assessment procedures; there is no Czech type approval in the text. §1(3) is the Czech-specific point worth noting: the government decree implementing the Low Voltage Directive does not apply to radio equipment at all, except for the §3(1)(a) health and safety requirement, which is imported into the radio decree without its voltage threshold. §3(1)(b) does the same for electromagnetic compatibility. Under §40 of zákon 90/2016 Sb. the general surveillance authority is the Česká obchodní inspekce unless another act designates a different body; the Český telekomunikační úřad publishes the delegated-act radio categories in the Telekomunikační věstník under §3(3).

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 Czech Republic routes to check

Check every Czech Republic route →

Electrical safety

MDR electrical safety in place of the Low Voltage Directive

Evidence is normally handled inside the medical-device registration route.

EMC

MDR electromagnetic compatibility in place of the EMC Directive

Evidence is normally handled inside the medical-device registration route.

Environmental / battery

Nařízení vlády 481/2012 substance restriction (RoHS)

Evidence may be required, but the matrix does not identify a generic separate certificate.

Environmental / battery

Seznam výrobců registration, with liability shifting to the distributor

Applies when the product, feature, component, or use is in scope.

Environmental / battery

Batteries Regulation not yet reflected in the national act

A transition is identified; the applicable date and current status must be checked.

Metrology

CMI mandatory verification of measuring devices

Applies to the facility, operator, or installation rather than only the product.

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.

e-Sbírka (Elektronická Sbírka zákonů a mezinárodních smluv)

Nařízení vlády 426/2016 Sb. §§ 1 and 3 — radio conformity and the Low Voltage Directive carve-out

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 Czech Republic 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 Czech Republic?: 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.