In light of a recent ruling from the European Court of Justice, the French Council of State has struck down provisions of a law which allowed extra certification for medical prescription assistance software.
In 2017, the European Court of Justice ruled that medical prescription assistance software should be classed as a medical device, and therefore require CE marking in certain circumstances. As a result, software which satisfies these conditions is under the remit of Article 4 of the Medical Devices Directive, which forbids member states from ‘obstructing on their territory the placing on the market and putting into service of devices bearing the CE marking’.
Subsequently, on 12 July 2018 the French Council of State cancelled Articles 1, 2 and 3 of Decree 2014/1359, which had allowed the High Authority for Health to provide extra certification for medical prescription assistance software. This means that medical prescription assistance software in France is subject to the same regulatory requirements as any other medical device.
Read more on the recent court judgement’s implications for the French medical device market, and France’s product licensing regime in general, on MAP Medtech’s France Section: