A new legislation for MEDDEV-Requirements
Since mid-2012 the draft version of the new EU regulation is being controversially discussed.
Besides the time frame for implementation of the regulation, it is all about the content and the results.
Since then a release is clearly on the horizon. For clinical evaluation it means that requirements from the revised MEDDEV document may become law. After all the European Commission has adopted the text of the document for the draft version of the regulation.
On condition that the EU Parliament agrees with this new legislative text a more stringent monitoring of the compliance with the specifications will take place. The present version of the medical device regulation can be found on the website of the European Commission.
The European Commission or EU Commission is a supranational institution of the European Union. In the political system of the EU the Commission plays the executive role, which means being in charge of decision-making process of EU legislative acts (guidelines, regulations, resolutions of the European Parliament). The Commission’s right of initiative entitles the body to draw up proposals for a new legislation.
The recent comments of the Parliament may be viewed on website of ENVI.
The European Parliament located in Straßburg is the Parliament of the European Union.