NEWS
The EN ISO 18113 series outlines key requirements that manufacturers must provide for information accompanying in vitro diagnostic (IVD) medical devices, including the product label and instructions for use. It encompasses various aspects of IVD medical devices, with specific parts in the standard series dedicated to reagents and instruments intended to meet the specific needs of both professional and self-testing users.
ANEC was pleased to contribute to the Committee on the Internal Market and Consumer Protection (IMCO Committee)’s exchange on the “European Standardization Policy: Exchange of Views with the Commission” on 5 September 2024 at the European Parliament.
The European Commission is currently proceeding with the evaluation of Regulation 1025/2012 on European Standardization to determine whether the legislation is still fit for purpose as the basis for the European standardization system. In the framework of the evaluation, the EC launched a public consultation over the summer, to which the ETUC replied, together with a number of trade unions.
The new political mandate of the EU institutions, along with the ongoing evaluation of Regulation 1025/2012 on European standardization and the calls for a stronger and more competitive Single Market of the Letta and Draghi reports, put SMEs and standardization at a crossroads. Understanding the importance of this moment, SBS publishes its “Manifesto for the 2024–2029 EU term – SMEs at the heart of European standardization.”
At the Slovenian Institute for Standardization (SIST), summer was anything but quiet, as SIST diligently prepared for numerous fall projects that bring fresh opportunities for learning and collaboration.
The content of this proposed CEN Workshop Agreement (CWA) is developed as part of the Horizon Europe project n. 101121167 TeamUP “Holistic capability and technology evaluation and co-creation framework for upskilled first responders and enhanced CBRN-E response”.
The twin green and digital transitions open new opportunities for the European industry and citizens, in a quickly changing global scenario. But does Europe have what it takes to meet today and tomorrow’s challenges? How can we make sure that it has the skills and the workforce to remain competitive in the global economy? And what is the role of standardization?
This CEN-CENELEC Workshop intends to develop two CWAs related with the automation of road maintenance technologies.
The July issue of the CEN-CENELEC newsletter 'On The Spot' is out now!
Regulation 1025/2012 on European Standardization is the key legal framework that facilitates the effective public-private partnership between CEN and CENELEC and the European Union/EFTA. Regulation 1025/2012 is currently undergoing evaluation by the European Commission, including a public consultation via a questionnaire that took place on the Have Your Say platform from 2 May 2024 to 25 July 2024.