General Background Information to the EU Agreement

Regulations on Medical Devices (MDR) and In-Vitro Diagnostic Devices (IVDR) were reached at a political level between the three relevant European institutions (the European Council, the European Parliament, and the European Commission) and came into force in May 2017 after publication in the Official Journal of the European Union. The Regulations originally had a six-month transition period, with some features becoming legally binding. However, because of the global outbreak of Covid-19, complete implementation has been postponed, and after a five-year transition period, the IVDR will become fully operational on May 26, 2022.

The MDR and IVDR will replace the original Directives, which have been in force for almost 25 years, and will constitute a significant development and strengthening of Europe’s existing regulatory system for medical devices. 

As a Regulation rather than a Directive, it is directly applicable at the national level without the need for specific national legislation. This should provide more legal certainty and prevent differences in the strategy chosen or the rules governing medical devices among the EU Member States

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