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FAQ's – CLASS IIb and III Devices
Are
Class IIb devices going to be re-classified as Class III?
All
Standards go through a review process every 5 years. The output of the review
is either to;
· keep the standard in it’s present form, or
· review and amend the current standard, or
· completely review and re-publish (for example, like the
full re-vamp of IEC 601-1 (EN 60601-1 which is currently being undertaken)
The
Medical Device Directive 93/42/EEC is presently going through it’s 5 year
review, and the full outcome is currently unpublished, as all 15 Competent
Authorities + the European Commission, must agree any changes.
There is
presently talk of “….up classifying Class IIb devices to Class III…..”. The
Implications of such a re-classification would be horrendous for device
manufacturers, because Class III devices require a Design Dossier, whereas
Class IIb do not.
If the change
is approved, then it would only apply to Implantable devices.
So the advice
is…..”…..watch this space…..”
If you
have specific questions on this or other Classification issues, please email
your question to:
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