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The EMKI Certification Office – under the professional supervision of the Ministry of Health and the Office of Health Authorisation and Administrative Procedures (OHAAP) – as a Notified Body with identification number 1011 conducts conformity assessment procedures according to Council directive 93/42/EEC concerning medical devices, council directive 90/385/EEC concerning active implantable medical devices and 98/79/EC concerning in vitro diagnostic medical devices.  Apart from this as an accredited certifying body – under the professional supervision of the Hungarian Accreditation Board – it conducts quality management system certifications according to standards EN ISO 9001:2008 and EN ISO 13485:2003.