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medical devices

This tag is associated with 4 posts

Medical devices and in vitro diagnostic medical devices [EU Legislation in Progress]

Written by Nicole Scholz (4th edition) Medical devices and in vitro diagnostic medical devices cover a wide array of products. The EU legal framework for such devices was harmonised in the 1990s. The European Commission presented a pair of proposals for regulations in September 2012. Following Parliament’s first readings in April 2014, the Council agreed … Continue reading

Medical devices and in vitro diagnostic medical devices [Plenary Podcast]

Written by Nicole Scholz, The current EU approval system for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) is based on conformity assessment by ‘notified bodies’. A number of scandals stressed the need to tighten the regulatory framework for such devices. The European Commission’s proposals for regulations on MDs and IVDs, being discussed … Continue reading

In vitro diagnostic medical devices

Written by Gregor Erbach In vitro diagnostic medical devices are tests used on biological samples to determine the status of a person’s health. The industry employs about 75 000 people in Europe, and generates some €11 billion in revenue per year. In September 2012, the European Commission (EC) published a proposal for a new regulation on … Continue reading

Safe and innovative medical devices

6 language versions available in PDF format Unbedenkliche und innovative Medizinprodukte Productos sanitarios innovadores y seguros Dispositifs médicaux sûrs et innovants Dispositivi medici sicuri e innovativi Bezpieczne i innowacyjne wyroby medyczne Safe and innovative medical devices Innovation in medical devices benefits patients, doctors and the medical technology industry. The European Commission has proposed legis­lation aimed … Continue reading

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