Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation
The European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings. The regulations ...
Consultation, EU, IVDR, MDR
The European Commission’s Directorate-General for Health and Food Safety has published MDR and IVDR Language Requirements for Manufacturers.
The EU is made up from 27 countries, most of them having their own national language. Since there is no official language of the European Union, each member state has different requirements that would need to be respected when making a device available in a particular member state. The MDR and IVDR both contain legal ...
