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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 : 31 - 40 of 83
Areas of interests : Authorised Representatives, Importers and Distributors
Release Date : Feb 14 2018 | Country : Portugal | Language : Portuguese

This is a draft of a designation request to a Notified Body in the area of medical devices.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors
Release Date : Feb 14 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.

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 : Feb 08 2018 | Country : Ireland | Language : English

The purpose of this document is to provide guidance to industry on distribution of medical devices, in vitro diagnostic medical devices, and their accessories for human use in Ireland.

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 MDR.

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 the reprocessing of disposable products 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 report from a subgroup to the German National Working Group on the Implementation of MDR and IVDR provides some clarifications on the transitional requirements of the Regulations.

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 national topics related to Notified Bodies as well as critical questions from European working group discussions related to 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 presentation from the German National Working Group on the Implementation of MDR and IVDR compares market surveillance requirements under the eXisting legislation and the new Regulations and also discusses clinical assessment and trials.

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

This document contains FAQ related to clinical trials and performance studies on IVD under the MDR and IVDR.

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

This presentation from a subgroup of the German National Working Group on the Implementation of MDR and IVDR discusses clinical trials/performance studies, including procedures for the participation of ethics committees in clinical trials, along with other issues.

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