Slovakia government has approved an interim version of the regulation on the technical requirements and conformity assessment procedures for medical devices. This version of the rules is effective from June 23, 2020 to May 25, 2021.
These government regulations reflect the legally binding laws of the European Union, such as:
– Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
– Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices
– Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices
– Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devicesmanufactured utilising tissues of animal origin
– Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devicces
– Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
According to this regulation, medical devices are classified according to the degree of risk due to their use on the human body.
1. Class I
2. Class IIa
3. Class IIb
4. Ciass III
The conformity assessment procedure is based on the EU scheme set out in Council Directive 93/42/EEC, and medical devices must be provided with instructions and instructions to assist customers in using the device safely and correctly.