A Step Forward for New EU Medical Device Legislation

Monday, June 22, 2015

Source: RAPS

After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation.

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A Step Forward for New EU Medical Device Legislation

Monday, June 22, 2015

Source: RAPS

Regulators in Europe have been discussing the need to reform the legislative framework for medical devices and IVD for many years.

In the EU, the legislative process is structured so that only the EC can initiate new legislation. The European Parliament then votes on the commission's proposal and legislative texts, making any amendments it chooses. Once the parliament has adopted a proposal, the European Council is tasked with adopting a general approach before beginning a trilogue with the parliament and commission to work toward a final text.

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