New legislation for medical devices


On Friday 26 May, two new medical technology directives come into force. The new legislation has been negotiated within the EU.

The purpose of the directives adopted – one for medical devices and one for medical devices for in-vitro diagnostics – is to adopt a powerful and sustainable regulatory framework that guarantees a high level of health and safety and supports innovation.

The directive covering medical devices shall start being implemented three years after coming into force, i.e. 26 May 2020, while the directive covering medical devices for in-vitro diagnostics shall be implemented five years after coming into force, on 26 May 2022.

Source: lakemedelsverket.se


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