Useful links

Hungarian legislation of medical devices:

• 4/2009. (III. 17.) Decree of the Minister of Health on medical devices

• 8/2003. (III. 13) Decree of the Minister of Health, Social and Family Affairs on in vitro diagnostic medical devices

Other regulations considering the certification:

• Act CXXXIII of 2009 on activity of organisations performing conformity assessment activity

• 315/2009. (XII. 28.) Decree of the Government on notification of organizations attending conformity assessment and about detailed rules of the notified organizations’ activity

• 18/2010. (IV. 20.) Decree of the Minister of Health on special rules of notification of those organizations attending conformity assessment and seized of the distribution requirements, which are in the regulatory competence of the Minister of Health, and of the notified organizations’ activity

• Regulation of unannounced audits: 2013/473/EU: Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices

Directives:

• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices(hereinafter referred to as AIMDD)

• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (hereinafter referred to as MDD)

• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (hereinafter referred to as IVDD)