NEOEMKI LLC. (National Medical Device Conformity Assessment and Certification LLC.) is a business organization owned by the Hungarian State.
NEOEMKI LLC. was established with the aim of carrying out the conformity assessment of medical devices and in-vitro diagnostic devices as a Notified Body, and as an accredited certification body for the certification of quality management systems as per EN ISO 9001 and EN ISO13485 standards.
NEOEMKI LLC. after its establishment became the legal successor of EMKI Directorate of Device Testing and Clinical Engineering in relation to medical device conformity assessment activities.
Thanks to last years professional activities, consecutive reformation and development, NEOEMKI LLC. have a remarkable clientele, and is a known certification organisation internationally, not only in Europe but also on the American, Asian and African continent.
NEOEMKI LLC. perform certification routine in compliance with the rules of the Code of Conduct of the Team NB, an association of European medical certification organizations, corresponding to the highest requirements.
Professional activity of NEOEMKI is based on a remarkable, almost a half-century tradition.
Our predecessor in title, known as ORKI (National Institute of Hospital and Medical Engineering), was founded in 1962 and operated as national testing laboratory in the field of medical devices.
Since 2001 ORKI started working as a Notified Body.
After Hungary has joined the European Union, ORKI turned up on European certification market.
The organisation has been renewed in year 2008 responding to the change in medical device certification within the EU and performs its task under the name of EMKI (Directorate of Device Testing and Clinical Engineering).
After several reorganizations, the directorate continued to operate as one of the departments of GYEMSZI from 2011.
With the establishment of the National Institute of Pharmacy and Nutrition, the EMKI department continued to operate within the framework of the institute.
Following the establishment of NEOEMKI LLC. (March 27, 2020), became the legal successor of the OGYÉI EMKI department in respect of certification tasks related to medical devices, from 1st May 2020.
Main events of the legal predecessors of NEOEMKI LLC.:
1962: Establishment of the National Institute of Hospital and Medical Engineering (ORKI).
1990: ORKI became responsible for medical device conformity assessment activities.
2000: Designation of ORKI for device certification
The Minister of Health assigned the National Institute of Hospital and Medical Engineering (ORKI) as a notified body for certifications.
ORKI was an independently managed budgetary organization.
2008: Modification the deed of foundation (establishment of EMKI)
New name: EMKI (Institute for Healthcare Quality Improvement and Hospital Engineering)
2011: Establishment of National Institute of Quality and Organizational Development in Healthcare and Medicines (GYEMSZI)
2015: Establishment of National Institute of Pharmacy and Nutrition (OGYÉI)
EMKI (Directorate of Device Testing and Clinical Engineering).became one of the departments of OGYÉI.
2020: Foundation of NEOEMKI LLC.
NEOEMKI LLC. became the legal successor of the OGYÉI EMKI (Directorate of Device Testing and Clinical Engineering) department.