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Tuesday, June 1, 2010

the NEW MDD for CE Marking from March 21, 2010

New MDD for CE Marking to become mandatory on March, 21 2010

The Medical Device consolidated Directive, MDD 93/42/EEC will become mandatory on March 21, 2010. This means that all medical device manufacturers have to review their compliance to this directive and be in compliance. OTHERWISE they have to stop selling their devices in the European community.
This is especially critical for the new classification rules, if a Class I device is now classified as Class II a or b, or from Class II to Class III, a new conformity assessment is required. So it is URGENT to conduct a review of your technical file to the new MDD requirements and classification rules, or risk having to stop selling the device.


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