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Guidelines for medical devices and update of harmonized standards

On January 22, Order of the Ministry of Health of Ukraine No. 142 "On Approval of Methodological Recommendations on Application of Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013, Technical Regulations on medical devices for in vitro diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013 and Technical Regulations regarding Active Implantable Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013, was published. The Order approves methodological recommendations:

  • Classification of medical devices;
  • Medical devices. Accessories. Manufacturer;
  • Homogeneous lots;
  • Subcontracting - connection with the quality management system;
  • "Use before" date;
  • Scope of application of the Technical Regulations on active implantable medical devices, approved by the Cabinet of Ministers of Ukraine from 02.10.2013 № 755;
  • Authorized representative.

The approved guidelines have been developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of the rules of Technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding but should be considered manufacturers, authorized representatives, conformity assessment bodies and state market surveillance authorities, and other market operators of medical devices.

Guidelines for medical devices in Ukrainian language | in Russian language 

The Ministry of Health of Ukraine by its Decree dated January 20, 2020 No. 117 "On Amendments to Certain Orders of the Ministry of Health of Ukraine" approved the list of national standards, compliance with which provides the presumption of compliance of medical devices with the requirements of the respective Technical regulations. The list is based on the Orders of the Ministry of Healthcare of Ukraine dated 11 October 2017 No. 1242, No. 1243, No. 1244, however, with updated of information about the version of standards.

Order of MoH No.117 and Annexes in Ukrainian 

 

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