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By: Ludger Möller
News and Views: High Priority
May 2007
Content: Update of the Medical Devices Directives
Update of the Medical Devices Directives
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.
Should you have any questions or would like to have any
clarification, please do not hesitate to contact us. Our idea is
to collect all questions and provide feedback to all clients
accordingly. Certainly you should receive feedback on your
questions as soon as possible.
Your MDSS Team.
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