Slovakia Issues Temporary Regulations for Medical Devices
The Government of the Slovak Republic approved a temporary version of the regulation on technical requirements and conformity assessment procedures for medical devices. This version of the regulation is going to be effective from June 23, 2020 to May 25, 2021.
This Government Regulation reflects such legally binding acts of the European Union 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 devices manufactured utilising tissues of animal origin
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices
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 Regulations medical devices are classified with regards to the degree of risk resulting from their use to the human body:
Conformity assessment procedure is based on the EU Schemes as stated in the Council Directive 93/42/EEC.
Each medical device must be accompanied with the user manual/instruction that helps the client to use the device safely and correctly.
For conformity assessment procedure, Slovak technical standards according to the Law No 60/2018 are used to show the compliance of the medical device with this Regulation.
In case when there are no harmonized Slovak technical standards for the device or the existing Slovak technical standards do not specify all technical safety requirements, the compliance of the device can be proven on the base of ISO standards.
Please, remember, if a medical device can be referred as machinery it is also necessary to meet the compliance of the Slovak Government Regulation No 436/2008 on technical requirements and conformity assessment procedures for machinery
When placing medical devices on the market or putting them into service, the data must be in the state language. A manufacturer or his authorized representative may also attach data to the medical device in electronic form.
Please, note that medical devices may be placed on the market of the Slovak Republic only if they meet the technical requirements of this Government Regulation.
The full text of the regulation you can here.
The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.
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