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MAGYAR

Information about change on legislative requirements in prospect

5th May 2017 new standards were published in Official Journal of the European Union about medical devices (MDR) and IVD devices (IVDR): 

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC and 

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 

Full version of directives are available here: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC 

Interim phase of the two directives are different: in case of devices covered by MDR, it is 3 years, in case of devices covered by IVDR, it is 5 years for manufacturers to convert to the new regulation. 

In case of any question please turn to us with confidence via e-mail on the following addresses: emki.titkarsag@ogyei.gov.hu or cert@emki.hu, our colleagues are available.

Last updated: 2017.10.17 15:44