Does my medical device need 197/2014. (VIII. 1.) Korm. rendelet on waste electrical and electronic equipment in Hungary?

Maintained country rule

What this 197/2014. (VIII. 1.) Korm. rendelet on waste electrical and electronic equipment check is screening

Identifies RoHS, WEEE/EPR, battery, recycling, and producer obligations without miscalling them safety certificates. Applies when the product, feature, component, or use is in scope.

Requirement family

Environmental and battery obligations

Regulatory object

electrical electronic medical device

Maintained rule status

mandatory if feature

Useful product facts

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

1. § (2) j) keeps out of scope medical devices and in vitro diagnostic medical devices expected to become infective before the end of their life cycle, together with active implantable medical devices; every other medical device inside the 1. melléklet categories is covered, with equipment defined in 2. § (1) 2. as working at up to 1000 V AC or 1500 V DC. The operative duty for a manufacturer is take-back rather than a certificate: under 4. § (1) the producer under individual compliance, or the concession company under collective compliance, must take back its own waste equipment and equipment of the same nature and function placed on the market by others, and 3. § lets the producer refuse a used device only where it presents a serious risk to the health or physical safety of the person taking it back, in which case the item is treated as waste. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.