Jun 20, 2019

Les autorités européennes désignent les entités d'attribution de l'IUD

Quatre entités désignées comme émettrices d'IUD pour l'Union européenne
Nov 28, 2011

Eucomed Proposed EU Regulatory Fixes

European medical technology trade association Eucomed has issued a new position paper advocating six major...
Jul 22, 2011

Draft Rules on Electronic Instructions for Use Published by EU

The European Commission has published draft regulation covering electronic instructions for use in the European...
Apr 21, 2011

Regulatory Updates affecting the EU Market

The European Commission has issued a new version of the "Manual on Borderline and Classification...
Mar 31, 2011

EU Considers Applying Transparency Directive to Medical Devices

The European Commission may extend its Transparency Directive covering pricing and reimbursement transparency of medicinal...
Mar 23, 2011

Eucomed: Ease Regulatory Requirements for Smaller-tier Medical Device Makers

European medical device industry trade group Eucomed has issued four major recommendations to the European...
Feb 17, 2011

Eucomed Proposes Wider Adoption of Remote Cardiac Device Monitoring Tools

European medical device trade association Eucomed has made adoption of technology to remotely monitor implantable...
Dec 28, 2010

New Adverse Event Reporting Guidelines for Europe

The European Commission has issued new guidelines for how entities conducting clinical trials should report serious adverse events to appropriate national competent authorities (NCAs). The new rele
Dec 15, 2010

40-year EU Patent Impasse at an End?

The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a mor
Jun 11, 2009

European Commission issues interpretation of Directive 2007/47/EC

The European Commission has issued an interpretative document (dated 5 June 2009) of Directive 2007/47/EC...