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Library

Library

The Library is your entry point to a comprehensive database of documents produced by stakeholders throughout the European Union related to medical devices and in-vitro medical devices, in addition to and to all relevant websites. The Library also includes all key resources produced by DG GROW related to the Regulations on medical devices and in-vitro medical devices.

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You can use the tool below to filter through our database of external resources by year, country, language and area of interest to find the documents you require.

Showing results : 51 - 60 of 83
Areas of interests : Healthcare professionals and health institutions
Release Date : Jan 01 2018 | Country : Romania | Language : Romanian

This Activity Report from the Romanian National Agency for Medicines and Medical Devices for 2017 includes information on participation in debates on the finalisation of proposals for the MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 01 2018 | Country : Switzerland | Language : Italian

This document outlines Swissmedic’s involvement, as a competent authority, in collaboration with the Federal Office of Public Health, in legislative changes related to medicinal products and medical devices.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 01 2018 | Country : Switzerland | Language : English

This report includes some coverage of the impacts in Switzerland of the new MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 01 2018 | Country : Switzerland | Language : French

This document outlines Swissmedic’s involvement, as a competent authority, in collaboration with the Federal Office of Public Health, in legislative changes related to medicinal products and medical devices.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 01 2018 | Country : Switzerland | Language : German

This document outlines Swissmedic’s involvement, as a competent authority, in collaboration with the Federal Office of Public Health, in legislative changes related to medicinal products and medical devices.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Dec 01 2017 | Country : Sweden | Language : Swedish

This report discusses the implications of the MDR, particularly related to traceability, implants, reprocessing, products without a medical application and genetic testing.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors
Release Date : Nov 30 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.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Nov 26 2017 | Country : Ireland | Language : English

This document provides guidance to conformity assessment bodies and notified bodies currently designated under the eXisting medical devices and in vitro diagnostic medical devices Directives when making designation applications to the Irish Health Products Regulatory Authority.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Nov 09 2017 | Country : European Union | Language : English

This MedTech Europe Position Paper on Article 50 Negotiations between the European Union and the United Kingdom discusses what this process will mean with regards to the new Regulations.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Nov 07 2017 | Country : European Union | Language : English

This roadmap from the EU Competent Authorities for Medical Devices (CAMD) outlines priorities for facilitating an effective implementation of the MDR and IVDR.

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