Det Indre Marked, Erhvervspolitik, Iværksætteri og SMV’er

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.

Search external resources

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 : 1 - 10 of 83
Areas of interests : Manufacturers MD, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jul 27 2018 | Country : United Kingdom | Language : English

This BSI Group presentation covers technical document requirements under the European Medical Device Regulation (MDR).

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

This document provides a comparison between requirements under the MDR and IVDR and the MDD/AIMDD.

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

This timeline from BSI Group covers the stages in the transition to the MDR.

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

This set of MDR classification rules for non-invasive, invasive and active devices makes a comparison between requirements under the new Regulation and the MDD/AIMDD.

Areas of interests : Manufacturers MD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors, Healthcare professionals and health institutions
Release Date : Jul 27 2018 | Country : United Kingdom | Language : English

This detailed review of requirements and responsibilities for MDSAP participating countries regarding medical device vigilance reporting.

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

This guide from BSI Group covers the BSI certification process for medical devices, from initial application to the issuing of a CE mark certificate.

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

This timeline from BSI Group covers the stages in the transition to the IVDR.

Areas of interests : Manufacturers MD, Manufacturers IVD, Competent authorities in non-EU/EEA countries, Authorised Representatives, Importers and Distributors
Release Date : Jun 11 2018 | Country : Switzerland | Language : German

This document from scienceindustries Switzerland covers the consultation process for the Amendment of the Therapeutic Products Act (new medical device regulation) and the Federal Law on Technical Barriers to Trade.

Areas of interests : Healthcare professionals and health institutions
Release Date : Jun 01 2018 | Country : Germany | Language : German

This annual report from the German Hospital Society contains information on the National Working Group on implementation of MDR and IVDR.

Areas of interests : The procurement of MDs and IVDs, Healthcare professionals and health institutions
Release Date : May 31 2018 | Country : European Union | Language : English

This newsletter from the European Hospital and Healthcare Federation contains an article on a survey related to the introduction of the MDR and IVDR conducted among 169 professionals working in medical device and IVD firms.

Pages