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MHRA "New Legislation on Medical Devices"
Why is the legislation being changed?
20 years is a long time
The original European legislation was drafted over 20 years ago and since then there have been substantial changes. The number of Member States in the EU has more than doubled and there have been technological leaps in device technology.
As a consequence, the application of the existing medical devices directives is different across the EU. This makes it difficult for the legislation to achieve its objectives: the safety of medical devices and their free movement in the EU’s single market.
All of the current legislation regulating medical devices is in the process of being revised at European level. Read more here.
Last modified: Thu, 17 Jul 2014 11:47:47 BST