TP224 - Sklep o osnovnih zahtevah kakovosti za medicinske pripomočke iz obveznega zdravstvenega zavarovanja

An EU Regulation is a binding legislative act that must be applied in its entirety across the European Union. Unlike directives, regulations do not need to be transposed into national law and are directly applicable in all member states. Regulations are used when uniform application across all EU countries is essential.

Slovenian Regulation TP224 covers "Sklep o osnovnih zahtevah kakovosti za medicinske pripomočke iz obveznega zdravstvenega zavarovanja". There are 1 standards associated with this slovenian regulation.

Harmonized standards under TP224 are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of TP224, facilitating CE marking and free movement within the European Economic Area.