EU Council and Parliament will amend MDD and IVDD

Final drafts of the Medical Devices Directive (MDD) and In-vitro Medical Devices Directive (IVDD) have now been published. The regulations will be voted on by the European Council on 7 March 2017 whilst the European Parliament on 20 March 2017, and are expected to be officially published in late April or early May.

Copies of the final drafts can be downloaded from below link:

-Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

-Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

For more documents on medical devices, please visit the download archive page.