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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 : 11 - 20 of 83
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 : Apr 30 2018 | Country : Ireland | Language : English

This Irish Health Products Regulatory Authority newsletter from April 2018 includes articles on Notified Bodies designation, new device legislation and vigilance reporting.

Areas of interests : The procurement of MDs and IVDs, Healthcare professionals and health institutions
Release Date : Apr 30 2018 | Country : European Union | Language : English

This newsletter from the European Hospital and Healthcare Federation contains an article on a communications campaign by the Commission related to the introduction of the MDR and IVDR.

Areas of interests : Manufacturers MD
Release Date : Apr 28 2018 | Country : European Union | Language : English

This presentation provides an overview of the changes and impact of the Medical Device Regulation, from the point of view of a Notified Body.

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 : Apr 10 2018 | Country : Portugal | Language : Portuguese

This factsheet from the Portuguese Information Centre for Medicines and Health Products (CIMI) contains advice on transitioning to the MDR and IVDR.

Areas of interests : Manufacturers MD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Apr 06 2018 | Country : International | Language : English

This presentation, by a member of the Irish Health Products Regulatory Authority, deals with registries within the conteXt of the Medical Device Regulation.

Areas of interests : Manufacturers MD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Apr 06 2018 | Country : International | Language : English

This presentation by LNE Gmed discusses requirements for clinical evidence for medical devices when engaging with the new EU regulatory landscape.

Areas of interests : Manufacturers MD, Healthcare professionals and health institutions
Release Date : Mar 27 2018 | Country : International | Language : English

This document provides advice to regulators of medical devices and registry organizations on the use of registry-generated data in support of regulatory decisions.

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 : Mar 23 2018 | Country : Belgium | Language : English

This presentation deals with UDI tracing and reporting requirements in the MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Mar 21 2018 | Country : Germany | Language : German

This report covers market surveillance requirements under the MDR and the IVDR.

Areas of interests : Manufacturers MD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Mar 21 2018 | Country : International | Language : English

This presentation, by a member of the Irish Health Products Regulatory Authority, deals with the clinical impact of the Medical Device Regulation.

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