Internal Market, Industry, Entrepreneurship and SMEs

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 : 21 - 30 of 83
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.

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

This presentation by TÜV SÜD covers the needs of Notified Bodies related to scientific eXpertise for evaluating clinical evidence.

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

This is a Summary Report from a European Society of Cardiology (ESC) meeting that discussed the safety and performance of medical devices, how the new European regulatory landscape impacts that, and what opportunities lie ahead for the involvement of eXperts in the regulatory process.

Areas of interests : Authorised Representatives, Importers and Distributors
Release Date : Mar 21 2018 | Country : European Union | Language : English

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

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Healthcare professionals and health institutions
Release Date : Mar 21 2018 | Country : European Union | Language : English

This presentation by the European Commission covers EU governance according to the new medical devices Regulations and highlights some of the main features of the new teXts.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Healthcare professionals and health institutions
Release Date : Mar 21 2018 | Country : European Union | Language : English

This presentation by the European Commission deals with advisory structures under the new medical devices Regulations, highlighting the functions of eXpert panels and laboratories.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Mar 20 2018 | Country : Belgium | Language : Dutch

This presentation from the Dutch Federal Agency for Medicines and Health Products deals with vigilance requirements related to IVDs under the new Regulation.

Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Mar 06 2018 | Country : Sweden | Language : Swedish

This report contains information for manufacturers and other stakeholders related to the implementation of the MDR and IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Feb 27 2018 | Country : United Kingdom | Language : English

This BSI Group presentation deals with QMS aspects related to the MDR and IVDR, highlighting what needs to be done now and what in the future.

Areas of interests : Manufacturers MD, Healthcare professionals and health institutions
Release Date : Feb 23 2018 | Country : International | Language : English

This position paper discusses 3D printing of custom-made devices in the dental industry within the conteXt of the MDR.

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