EMKI

Directorate of Device Testing and Clinical Engineering, known as EMKI, as part of National Institute of Pharmacy and Nutrition provides state function as well as performs conformity assessment of medical devices, being a certifying organisation, registered in NANDO system

EMKI, as a Notified Body, with identification mark CE 1011, performs conformity assessment of medical devices and as it is accredited certifying organisation, assess quality systems according to ISO 9001 and 13485 standards. Part of duties is to perform laboratorial tests on medical devices and technical instruments and issues certificates about technical and professional parameters of devices and marketing authorization documents for reinbursement process.

EMKI keeps trainings about the requirements of putting on market a medical device and on professional events its experts regularly give information about general expectations.

Thanks to last years, professional activities, consecutive reformation and development, EMKI has a remarkable clientele, and is a known certificatory organisation internationally, not only in Europe but also on American, Asian and African continent.

EMKI performs its certification routine according to rules of Code of Conduct (document of leading medical device Notified Bodies in Europe) and corresponds to the highest requirements.

Overview

EMKI’s professional activity bases on a remarkable, almost a half-century tradition.

Our predecessor in title, known as ORKI, was founded in 1962 and operated till 2001 as national testing laboratory in field of medical devices. Since 2001 it has been functioning as Notified Body, then, after Hungary has joined to the European Union, ORKI turned up on international certification market. The organisation has been renewed in year 2011 responding to the change in medical device certification within the EU and performs its task under the name of EMKI.

Contact

Address: H-1097 Budapest, Albert Flórián út 3./a

Phone: (+0036 20) 268-7595

Fax number: (+0036 1) 886-9460

E-mail: cert@emki.hu

 

Information about change on legislative requirements in prospect

Information about change in standard requirements

General information about EMKI’s certificating activity

Documents related to EMKI’s operation

Certificates

Certificating quality systems according to ISO 9001 and 13485 standards under the professional control of NAH accreditation body

Certification of medical devices and compliance audit according to 93/42/EEC directive

Certification of IVD devices and compliance audit according to 98/79/EC directive

Downloadable forms

Last updated: 2017.10.16 18:01