Slovakia has approved the provisions of the technical requirements and conformity assessment procedures for active implantable medical devices.
It will take effect from June 23, 2020 to May 25, 2021.
These provisions temporarily change the following legally binding provisions of the European Union.
– Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
– Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
– Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
According to the applicable regulations, technical safety requirements are divided into:
– General safety requirements
– Design and production requirements