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 : 81 - 83 of 83
Areas of interests : Manufacturers MD, Manufacturers IVD, Healthcare professionals and health institutions
Release Date : Dec 19 2016 | Country : Sweden | Language : Swedish

This market plan for Medical Devices discusses some of the implications of the introduction of the MDR, including the expanded supervisory responsibility of the Swedish Medicines Agency.

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 : Sep 09 2016 | Country : Ireland | Language : English

This document applies to system and procedure packs containing products that fall within the definition of a medical device under Council Directive 93/42/EEC. Active implantable, in-vitro diagnostic medical devices, and medicinal products are outside the scope of this document.

Areas of interests : Manufacturers MD, Manufacturers IVD, The procurement of MDs and IVDs
Release Date : Feb 06 2015 | Country : Sweden | Language : Swedish

This presentation on the MDR deals with the road to CE marking, what the new Regulation aims to achieve, and new requirements for clinical evaluation and trials.

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