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