Revising the IVDD - a new risk classification for IVDs in Europe?

The European Commission has formally opened consultation on possible revision of the In Vitro Diagnostic Devices Directive (IVDD).  This follows earlier proposals to revise or "ReCast" the MDD of which more below.  Details of these reviews can be read here.

The big question is - what about the classification system - will Europe move to a risk based classification, in place of the current List A and List B system? If so  - what will that look like?

The likely answer: Look to the risk based classification developed in GHTF (actually from an original Australian proposal) and now adopted into the Australian system just a few days ago. This classification is also being picked up in ASEAN, is under active consideration at AHWP. and will almost certainly be the basis for revision of the EC IVDD.

When the initiative to "Recast" the MDD was floated a while back it was interesting how the UK MHRA responded. In their written submission they said...

 “the UK regrets that the [RECAST] questionnaire does not address the possible need for a fundamental review of the operation and effectiveness of the In Vitro Diagnostic Medical Devices Directive which we believe is now urgently required.”

They then said...

“In principle, the UK could support consideration being given to replacing the current listing system for In Vitro Diagnostic medical devices with a risk-based classification system.”

Given theat Europe is a founding member of GHTF - look to a push to pick up the GHTF risk classification in Europe.

The implications are considerable - most IVDs in Europe are not directly reviewed at the moment - being allowed to be marketed under CE self declaration. The GHTF risk classification changes all that, capturing a much larger proportion of devices marketed. This has caused considerable difficulty in Australia where most devices are imported and gain market access based on European Notified Body certification.

For further details on the Australian system - see the paper from Paul Cohen published in AIMS Journal.