en
Dictionary:

New legislation for medical devices

2017-05-17

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

Contact

Office for Clinical Studies, Swedish Research Council

Östra Hamngatan 26
SE-411 09 Göteborg

 

Phone (Swedish Research Council, switchboard):
+46 (0)31 757 41 75

E-mail: kliniskastudier@vr.se

Subscribe

Would you like to subscribe to news, good examples or calendar events from clinicalstudies.se?


Clinical Studies Sweden - a collaboration between The Swedish Research Council and the Swedish Association of Local Authorities and Regions.