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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 : 41 - 50 of 83
Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Feb 01 2018 | Country : Germany | Language : German

This report from a subgroup of the German National Working Group on the Implementation of MDR and IVDR deals with classification and vigilance under the new Regulations.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Feb 01 2018 | Country : Germany | Language : German

This is the German version of the FAQ from the Competent Authorities for Medical Devices related to transitional provisions for the IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Feb 01 2018 | Country : Germany | Language : German

This report from a subgroup of the German National Working Group on the Implementation of MDR and IVDR deals with new or changed requirements for medical device manufacturers and their products under the new Regulations.

Areas of interests : Manufacturers MD, 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 : Feb 01 2018 | Country : International | Language : English

This document provides a strategic overview of the impact of Medical Device Regulation (MDR) impact on the radiological, electromedical and healthcare IT sectors and is addressed to all parties involved in implementing the MDR.

Areas of interests : Manufacturers MD, Healthcare professionals and health institutions
Release Date : Jan 30 2018 | Country : International | Language : English

This Position Paper deals with how to classify "potential for internal eXposure" emanating from dental materials, in the conteXt of Rule 19 of the new Medical Device Regulation.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Jan 26 2018 | Country : Germany | Language : German

These FAQ deal with definitions and field safety corrective actions (FSCA) related to the MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 23 2018 | Country : United Kingdom | Language : English

This BSI Group presentation covers EU harmonisation and the impact of the MDR and IVDR on eXisting standards.

Areas of interests : Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 17 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.

Areas of interests : Manufacturers MD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jan 17 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.

Areas of interests : Healthcare professionals and health institutions, Health institutions reprocessing single-use medical devices
Release Date : Jan 01 2018 | Country : United Kingdom | Language : English

This briefing, aimed at anyone in NHS hospitals and organisations involved in the manufacturing or modification and use of medical devices and in vitro diagnostic medical devices, covers changes in the rules governing these activities.

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