Does my medical device need 374/2012. (XII. 18.) Korm. rendelet restricting hazardous substances in electrical equipment in Hungary?

Maintained country rule

What this 374/2012. (XII. 18.) Korm. rendelet restricting hazardous substances in electrical equipment check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Evidence may be required, but the matrix does not identify a generic separate certificate.

Requirement family

Environmental and battery obligations

Regulatory object

electrical electronic medical device

Maintained rule status

evidence only no separate certificate

Useful product facts

Battery chemistry/capacity, electrical equipment, importer/producer role, packaging, and market date.

Consolidated to 22 July 2026 on the Nemzeti Jogszabálytár. 1. § (2) h) excludes active implantable medical devices, and 2. § now defines that term by reference to Regulation (EU) 2017/745 rather than the repealed directives, so the decree is current. The Hungarian-specific dates sit in the transitional text: the DEHP, BBP, DBP and DIBP marketing restriction under 3. § (1) applies to medical devices including in vitro diagnostics, and to monitoring and control instruments including industrial ones, only from 22 July 2021, while the general date is 22 July 2019; and the restriction does not reach medical devices placed on the market up to 21 July 2014, in vitro diagnostics up to 21 July 2016 or industrial monitoring and control instruments up to 21 July 2017. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.