29 January 2010

Munich Seminar on Latest MDD Revision Coming in February

Q1 Productions’ one-day seminar in Munich will explain what a medical product manufacturer must do to be compliant with the latest MDD revisions.

What effects will the revision of the Medical Devices Directive (MDD) have, from the point of view of notified bodies, competent authorities and the industry, on basic and clinical requirements for devices? A one-day seminar being presented by US-based Q1 Productions in Munich on February 15, 2010, will go into this question.

The deadline for compliance with the latest revision of the MDD (directive 93/42/EEC) draws inexorably closer, and many medical technology manufacturers are struggling to meet the new requirements. Compliance with the revised elements must be fully achieved by March 21, 2010. Therefore, manufacturers, notified bodies and competent authorities are working to guarantee company conformity with the interpretations and revisions.

In order to ensure long-term conformity with the directive, it is essential to record, to the last detail, what the revisions mean for every medical product and company with respect to, for example, documentation, certification, clinical evidence and postmarket follow-through. For many medtech manufacturers, the reclassification of products is significant, as it brings into play requirements that did not concern particular products before.

The one-day seminar, which should be of interest to manufacturers based both in Europe and in the USA, will offer podium discussions about how the revisions are to be regarded from the point of view of manufacturers, notified bodies and competent authorities. The agenda, featuring presentations and discussions led by industry experts and authorities, offers manufacturers practical guidance relating to the final conformity tests. Speakers will concentrate on the most complex aspects of the latest MDD revisions and explain what has to be done in order to be in compliance. (Details can be found on-line at www.q1productions.com/eventPages/event_WSHOP-1005.php.)

For further information:

Q1 Productions
Chicago, IL, USA
www.q1productions.com