European Commission proposes new regulations for medical devices3 October 2012 The European Commission has proposed two regulations which it says will ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices [1,2]. The proposals are aimed at ensuring devices are fit for purpose, more transparent and better adapted to scientific and technological progress. The medical device sector is highly innovative, particularly in Europe and has an estimated market value of around €95bn [3]. The proposals have been submitted to the European Parliament and the Council. In order to become European Union law, the European Parliament and Council need to adopt the texts. Health and Consumer Policy Commissioner John Dalli said, "Just a
few months ago, everybody was shocked by the scandal involving
fraudulent breast implants which affected tens of thousands of women
in Europe and around the world. As policy makers, we must "The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union's market at the same time, they foster innovation and contribute to maintaining the competitiveness of the medical device sector." The European Radiological, Electromedical and Healthcare IT
Industry association, COCIR, has welcomed the move, saying new EU
Regulation could significantly improve the harmonisation of the EU The European industry association Eucomed, however, welcomed most of the recommended measures but voiced strong concern with regards to the 'scrutiny' procedure (see MTB Europe news Eucomed voices concern over scrutiny procedure in EC proposal for medical device regulations). Kevin Haydon, COCIR President said “It is crucial for the benefit
of European citizens to accelerate the uptake of innovative medical At the same time, it is essential that the regulation matches the
specificities of the sector, while continuously improving but also
avoiding an increase in the time to market and creating an
unnecessary administrative burden. This could hamper innovation and, COCIR believes that the current regulatory framework for its technologies is already adequate. There is however a need to modernise and strengthen it with efficient tools to enhance the traceability of the products and their critical components, harmonising EU Member States’ engagement and having a better coordination of the future regulatory framework, especially for the post-market phase. COCIR Secretary General, Nicole Denjoy said, “As an industry, we are calling for smart and efficient regulation guaranteeing transparency, patient safety, high quality and rapid access to highly-innovative medical technology and without significant increases in regulatory fees and costs. A reliable and simple regulation with the critical support of ‘state of the art’ standards for medical devices is essential to ensure safe and equitable access to healthcare in the European Union. COCIR will continue its efforts to contribute to better regulation and is ready to continue its dialogue with European Parliament and European Council. “This is a unique opportunity for regulators to find an efficient way to work together for smarter regulation in Europe and beyond. We welcome any initiative to strengthen the exchange of best practice between regulators as Maximum Safety is the primary goal for industry and all other stakeholders and is not only the responsibility of the regulators.” Who will benefit?
Main elements of the proposals
The revised regulatory framework for medical devices is comprised of the following:
Further information 1. For more information on the EC regulation proposals see: 3. EC web page with documents on the Revision of the medical
device Directives: 3. 2009 Eucomed figures for EU 27, Norway and Switzerland: www.eucomed.org/medicaltechnology/facts-figures 4. MTB Europe news: Eucomed voices concern over scrutiny procedure in EC proposal for medical device regulations.
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