Notranji trg, industrija, podjetništvo ter mala in srednja podjetja

Competent authorities in non-EU/EEA countries

Competent authorities in non-EU/EEA countries

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

You should also inform all importers of devices from the EU of the provisions for the transition from Directives to Regulations.

Clearly you 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

Key Resources

Related Resources

This is a list of the most recent relevant documents from the Library. For more, filter through our database by clicking on the View More button below.

Release Date : 21 March 2018 | Country : European Union | Language : English

This presentation by the European Commission deals with advisory structures under the new medical devices Regulations, highlighting the functions of eXpert panels and laboratories.

Release Date : 21 March 2018 | Country : European Union | Language : English

This is a Summary Report from a European Society of Cardiology (ESC) meeting that discussed the safety and performance of medical devices, how the new European regulatory landscape impacts that, and what opportunities lie ahead for the involvement of eXperts in the regulatory process.

Release Date : 21 March 2018 | Country : European Union | Language : English

This presentation by the European Commission covers EU governance according to the new medical devices Regulations and highlights some of the main features of the new teXts.

Release Date : 14 February 2018 | Country : European Union | Language : English

This document contains data concerning applications by Team-NB member Notified Bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.

Release Date : 17 January 2018 | Country : European Union | Language : English

These FAQ, compiled by the EU Competent Authorities for Medical Devices (CAMD), deal with transitional provisions for the IVDR.

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