Internal Market, Industry, Entrepreneurship and SMEs

Authorised Representatives, Importers and Distributors

Authorised Representatives, Importers and Distributors

The Regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the tasks that could be delegated by the legal manufacturer to the authorised representative. The Regulations emphasise a life-cycle approach to safety, adding requirements for pre-market clinical evidence and reinforced post-market monitoring (‘vigilance’ and ‘post-market surveillance’).

The Regulations also introduce a system of unique device identifiers (UDIs) to allow the identification of medical devices and facilitate their traceability. In addition, EUDAMED – the new European database for medical devices and in vitro diagnostic medical devices – will play a central role in making basic data widely available, and in reporting and tracking incidents.

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 from MedTech Europe outlines priorities for 2018 related to the introduction of the MDR.

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.

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 MDR.

Release Date : 30 November 2017 | Country : European Union | Language : English

This is a list of the Team-NB (The European Association Medical Devices - Notified Bodies) members’ intention to submit their application to be designated against MDR and/or IVDR.

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