The updated New Approach certainly will be considered by more Competent Authorities in the recast of the MDD, AIMDD
By the March 2010 deadline, notified bodies should no longer issue unlimited CE marking certificates (MDD 93/42/EEC Annex V and Annex VI, AIMDD
90/385/EEC Annex 2 and Annex 5): These are to be limited to a maximum of five years.
The MDD and AIMDD will remain with their originally issued monikers.
The following discussion describes the changes delineated in Directive 2007/47/EC as well as how these changes modify the MDD and AIMDD.
The MDD and AIMDD define a medical device more explicitly to include software as a category.
Both the MDD and AIMDD emphasize that the principal mode of action is the characteristic used to distinguish whether the product should be classified as a device or drug.
These items reflect the consensus position of its members on such issues as the demarcation between the MDD and AIMDD
Directive, definition of an accessory, classification of devices, translation procedures and much more.