The EU Medical Devices Regulation (MDR) 2017/745 entered into force at the end of May 2017 and will apply from 26th of May 2021, after a transitional period. It replaces the Medical Devices Directive (MDD).
The regulation aims to significantly improve the quality, safety and reliability of medical devices and market surveillance mechanisms.
QMS certification according to EN ISO 13485 standard
The EN ISO 13485 standard is important for developers, manufacturers and distributors of medical devices. In addition, manufacturers are increasingly expecting their suppliers and service providers to be certified.
The application of the EN ISO 13485 standard is an effective solution to ensure that your company fully complies with the requirements against the quality management system.
The application of the standard provides a solid basis for manufacturers to meet the requirements arising from their legal and social responsibilities, while demonstrating their commitment to the safety and high quality of medical devices.
Supervision of MD certificates issued under directive 93/42/EEC
Regulation (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (15th of March 2023) amended transitional rules of regulation (EU) 2017/745 (MDR).
According to MDR Art. 120. 3e) NEOEMKI LLC. has offered its supervision services for valid certificates legitimately issued under directive 93/42/EEC until 26th of September, 2024.
Supervision of IVD certificates issued under directive 98/79/EC
The certification of in-vitro diagnostic devices under Directive 98/79/EC (IVDD) was possible until May 26, 2022.
Based on Article 110 of Regulation (EU) 2017/746, we carried out the supervision of certificates issued by NEOEMKI LLC. under the scope of the above directive until September 26, 2025.
NEOEMKI LLC. is not designated for conformity assessment under Regulation (EU) 2017/746 (IVDR) and does not perform such activities.
