Medical Devices - New regulations

Competent authorities in non-EU/EEA countries

  1. Svenska
  2. English

Competent authorities in a non-European Union/European Economic Area country are recommended to make exporting manufacturers of MD and IVD, towards the EU, aware of the new Regulations, their obligations, and the transition timelines.

One of their responsibilities is to inform all importers of devices from the EU of the provisions for the transition from Directives to Regulations. Clearly they should also inform health institutions, procurers of devices, and customs officers.

They need to be aware of the changes, and especially of the fact that some Directive-compliant devices will remain on the market until 2025 and will coexist with Regulation-compliant devices. During this period valid certificates delivered by notified bodies and valid certificates of free sale delivered under the Directives and under the Regulations will be equally valid.

No discrimination should be made in the procurement of devices compliant with either the Directives or the Regulations.

Useful Information