Inflation of software medical devices – Part 2 – Software in Medical Devices

Via Scoop.ithealthcare technology


The most well-known (or widespread?) regulations are the 21CFR of the USA and the 93/42 directive of the European Union. The FDA has recently increased its number of inspections, mainly in foreigner countries. Even if FDA lacks of agents to do so, the trend is here. And an inspection of the FDA can be compared to being sued. If one day you have one, you’re not going to enjoy it! The regulations themselves don’t change but the FDA will to increase the law enforcement by foreign companies.

On the other side of the Atlantic Ocean, a new directive on medical devices is being drafted by the European commission. The content of this directive is still under construction but some new features are already known. The classification rules will change, for instance products which contain biological substances will be class III. The list of essential requirements will contain new ones, especially about software. This new directive should be released by 2013 or early 2014 and be active a few years later (remember that 2007/47 directive became mandatory in 2010).




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