CEN is producing European Standards to meet the requirements of the European Union Directives for medical devices (93/42/EEC), active implantable medical devices (90/385/EEC) and in vitro diagnostic devices (98/79/EC) that are acceptable to manufacturers, regulators and other interested parties.
References to the 'Harmonized' European Standards cited in the Official Journal:
The monthly
snapshot identifies work items for which (i) drafts have been received in CMC for formal vote or UAP, (ii) the formal vote or UAP has been launched, (iii) the formal vote or UAP is closed, (iv) standards which have become available within the last six months.
The CEN Advisory Board for Healthcare Standards (ABHS) is the sector forum for the Healthcare sector.
SPIDIA
'Standardization and Improvement of generic pre-analytical tools and procedures for in vitro diagnostics'
CEN is a full partner in this project under the EU's Seventh Framework Programme for Research and Development (FP7). CEN/TC 140 'In vitro diagnostic medical devices' will convert the findings of the SPIDIA project into European Standards and CEN Technical Specifications.
More information about SPIDIA.
Past events
CEN-CENELEC-COCIR Workshop on Medical Software, Brussels, 12 October 2011
EU calls for Reasearch and Innovation projects
On 20 July 2011 the European Commission launched a new wave of calls in the framework of the 7th Framework Programme (FP7) for Research and Innovation. Particular attention should be drawn to some Healthcare projects which include standardization related outputs.
Information on the contents of the calls per se is accessible on the EC dedicated website. The calls related to Healthcare that include standardization aspects are the following: HEALTH 2012.1.2-1 - HEALTH 2012.2.1.1-1 - HEALTH 2012.2.1.1-1-B - HEALTH 2012.2.1.1-1-C - HEALTH 2012.4.1-5.
Also visit our webpage explaining how standardization can contribute to the Research and Innovation efforts.
For any matter relating to participation in the FP7 Programme, or in general for any matter relating to the link between standardization and Research and Innovation, please contact research@cencenelec.eu.