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Hospital Healthcare Europe

New legal framework for medical devices


26 September, 2012  
The European Commission today adopted new Medical Device Regulation which now will be considered by the European Parliament and EU Member States. Now the legislative process starts. The European Radiological, Electromedical and Healthcare IT Industry association, COCIR, welcomes this important milestone. A new EU Regulation could significantly improve the harmonisation of the EU regulatory framework for medical devices across Europe and bring new products to clinical use faster.
The medical device industry has a proven track record of bringing to market highly- innovative technologies which have considerably reduced death rates, shifting the focus from sick care to preventive care. Kevin Haydon, COCIR President said “It is crucial for the benefit of European citizens to accelerate the uptake of innovative medical technology for the sustainability of healthcare systems across Europe, since we currently have an ageing population, a rise of chronic diseases, scarce healthcare workforce and an uncertain economic outlook.”
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, as a consequence, be detrimental to European citizens who would not be able to benefit from those innovations.
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.”
In a globalised world where such sophisticated products are designed and produced for the global market, COCIR calls for global harmonisation of regulatory frameworks, at a time when several other jurisdictions are also reforming their medical device regulatory frameworks. Nicole Denjoy continued, “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.”