Does my medical device need Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества in Bulgaria?

Maintained country rule

What this Наредба за пускане на пазара на ЕЕО във връзка с ограниченията за употреба на определени опасни вещества 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.

Приета с ПМС № 55 от 06.03.2013 г. (ДВ, бр. 24 от 2013 г., last amended ДВ, бр. 30 от 2016 г.). чл. 2(1) bans placing on the market electrical and electronic equipment, cables and repair, reuse, upgrade or capacity-increase spare parts containing the приложение № 1 substances above the concentration limits, and чл. 1(2) does not restate the categories but points at чл. 21е, ал. 2 ЗЗВВХВС, with the exclusions in ал. 3. §3(1) of the transitional provisions carries the Bulgarian-specific dates: the DEHP, BBP, DBP and DIBP restrictions in т. 7–10 apply from 22 July 2019 generally but only from 22 July 2021 to medical devices, in vitro diagnostics and monitoring and control instruments, and §3(2) leaves devices placed on the market before that date outside them. Exemptions are not granted nationally: чл. 3 sends the application to the European Commission, and the minister of environment and water then records the outcome by order under чл. 21д, ал. 3 ЗЗВВХВС. 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.