As pressure grows to harmonize global approaches for regulating medical software, representatives of leading European standards organizations and industry trade associations have met in Brussels to discuss the benefits of aligning standards with regulations on medical software.
A workshop jointly sponsored by the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR), the European Committee for Standardization (CEN), and the European Committee for Electrotechnical Standardization (CENELEC) brought together about 100 participants. These included regulators, members of the academic community, and industry representatives from Europe, Japan, and North America.
The workshop's objective was to take a global view on the current regulatory framework for medical software and identify threats and opportunities for industry and regulators. Its attendees expressed hope that there would be more clarity through European guidance expected before the end of 2011.
"COCIR's membership develops integrated solutions, including standalone software like user-friendly applications on smartphones and tablets," said Dr. Peter Linders, chair of the COCIR Technical and Regulatory Affairs Committee. "Such apps 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-centered solutions."