The updated text of the MEDICAL DEVICES DIRECTIVES has been approved by Parliament! The mandated review of the MDD has therefore been finalized.

Find the update here:
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+TA+P6-TA-2007-0091+0+DOC+XML+V0//DE

Please note that a full review of the AIMDD, the MDD and the IVD took place and not only the very limited review than initially required by the MDD. Therefore, the text refers to all directives and should thus be carefully evaluated!

Regarding the timeline: The text must be published in the Official Journal of the European Union. Once officially published member states will follow their own legal procedures to transpose the update of the directive into their national laws. All timelines will be provided by MDSS once available. However, since the text is approved, please be informed that most regulators consider the current update as “a clarification” of the old text only!! You may be confronted soon with some of the updates during any assessment procedures or competent authority inspections of your products.