BRUSSELS – 12 October 2011 – European medical software manufacturers are currently subject to a diverse and unclear regulatory framework within Europe and beyond. The harmonisation of global approaches for the regulation of medical software is urgently needed.

Today COCIR, CEN and CENELEC joined forces in Brussels to show the benefits of alignment of standards with regulations on medical software. MITA and JIRA, COCIR’s international partners in DITTA (Diagnostic Imaging and Therapy Trade Association) from the USA and Japan respectively, actively supported the event and were well-represented.

The Workshop brought together around 100 participants, among them regulators, industry and academics from Canada, Europe, Japan and the United States to take a global view on the current regulatory framework for medical software and identify threats and opportunities for industry and regulators with additional participants who were following the meeting remotely. There is a high expectation from the various stakeholders to bring clarity in the European space through the European guidance which will hopefully become available by end-2011.

Peter Linders, Chair of the COCIR Technical and Regulatory Affairs Committee, said “COCIR’s membership develops integrated solutions including standalone software like user-friendly Apps on smartphones and tablets which can reduce inequalities and bring improved access to healthcare to citizens. The supporting regulatory framework has to be clear, appropriate and innovation-friendly to allow fair competition and efficient patient-centred solutions.”

CEN CENELEC Director Standards Jean-Paul Vetsuypens said “Standards are essential tools to support efficient regulation. We welcome the participation today from leading standards developers and users from across the globe.”

*COCIR is the leading European trade association representing the medical imaging, electromedical and healthcare IT industry. CEN and CENELEC are European Standards Organisations.


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