AIMDDActive Implantable Medical Devices Directive
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107, Item 679--includes the MDD as well as the AIMDD and the InVitro Device Directive (IVDD).
The updated New Approach certainly will be considered by more Competent Authorities in the recast of the MDD, AIMDD and IVDD.
While it is still unclear whether the MDD and AIMDD will be amalgamated into one Directive, companies manufacturing, distributing or importing medical devices, particularly potential 'borderline products', will need to ensure that they keep up to speed with developments concerning the current framework, taking care not to fall foul of this ever evolving regulatory regime, whilst seeking to make the most of current opportunities within the healthcare industry.
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.
In late September, the long-anticipated revisions to the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) were published in Directive 2007/47/EC.
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.
The considerations, requirements and procedures for a notified body reviewing a device that incorporates, as an integral part, a substance that, if used separately, is a medicinal product, according to the medicinal product directive, is more thoroughly described in both the MDD and AIMDD.
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.