Does my medical device need 2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties in Hungary?

Maintained country rule

What this 2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties 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.

The Hungarian transposition of Directive 2014/53/EU, consolidated on the Nemzeti Jogszabálytár. 3. § (1) a) imports the safety requirements of the NGM decree on low-voltage electrical products expressly without applying its voltage limit, 3. § (1) b) imports the essential requirements of the NMHH EMC decree, and the same subsection ties radio-equipment design back to the national RoHS and WEEE decrees, so those obligations are not separable from the radio assessment. There is no Hungarian type approval. What is genuinely national is the language layer, and it is the part most often missed: 7. § (8) requires the manufacturer's name and contact address to appear in Hungarian on the equipment, its packaging or the accompanying documentation; 7. § (9) requires the operating instructions and safety information to accompany the equipment in both English and Hungarian; 15. § (3) and (5) require the EU declaration of conformity, and the simplified declaration, to be drawn up in Hungarian; and 7. § (14) lets the market-surveillance authority demand the whole compliance file in Hungarian. The market-surveillance authority is the Hivatal of the Nemzeti Média- és Hírközlési Hatóság, and 10. § (1) makes the distributor verify the Hungarian-language documentation before placing the equipment on the market.