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:
According to this regulation, technical safety requirements can be divided into the following categories:
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 email@example.com.