The Government of the Slovak Republic approved a temporary version of the regulation on technical requirements and conformity assessment procedures for active implantable medical devices. This version of the regulation is going to be effective from June 23, 2020 to May 25, 2021.

This Government Regulation transposes such legally binding acts of the European Union as:

• 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 this regulation, technical safety requirements can be divided into the following categories:

• General safety requirements  
• Design and production requirements

The conformity assessment procedures for active implantable medical devices is based on the stated EU Schemes as stated in the Council Directive 90/385/EEC.

Please, note that the active implantable medical devices may be placed on the market of the Slovak Republic only if they meet the technical requirements of this Government Regulation and if, when properly implanted, maintained and used in accordance with their intended purpose, the safety and health of patients, operating personnel or other persons.

The accompanying documents as well as marking details must be provided in the state language to meet the requirements of the Regulations.

The full text of the regulation you can find via 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. Need your own guide to the world of certification and approvals? Don't hesitate to contact us via info@gma.trade.

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