Due to some prominent medical device scandals in the past years, the European Commission introduced the MDR and IVDR with much stricter provisions in May 2017. mdi Europa introduces you to all relevant information.
To find out more about the MDR / IVDR subject, use the following links
MDR – Medical Devices Regulation (EU) 2017/745
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.
IVDR – In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
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.