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.  

Clinical Evaluation Requirements - Understanding the stricter European Requirements

One of the central components of the last update of the European MDD was to set out far more explicitly the requirements for Clincal Evaluation of devices.  The requirements had, of course, always been there.  Unfortunately they were so generally stated that the observance was not as widespread as it should have been  - particularly for lower risk devices. 

The new directives make the requirements and expectations much clearer.  This led to a lively debate recently on Linked In - in the Clinical Device Group Discussion Forum.  It was apparent from that discussion, mainly amongst US based RA professionals, that there's still some way to go in understanding of the tightened European requirements.

So what are the requirements?

Put Simply: every device must have, within the Technical File, Clinical Evidence to support its compliance with the Annex I Essential Requirements. At this point a simple equation and some definitions are helpful...

Clinical Evidence = Clinical Data + Clinical Evaluation

Clinical Data may, depending on the device nature and risk, be comprised of any mixture of literature, preclinical and engineering data and human clinical trial data.

Clinical Evaluation is the expert report which reviews the Clinical Data and reaches conclusions about compliance with the Essential Requirements based on that review and in particular the clinical performance of the device.

The Clinical Evaluation Report is a key part of the Technical File and needs to be updated from time to time as the device design evolves or more information comes to hand from postmarket experience - e.g. postmarket trials or from customer feedback, adverse events or other information which impact on the conclusions.

One last thing. Interpretations vary around the world (in other GHTF-model jurisdictions) as to who is qualified to sign off a Clinical Evaluation. The European interpretation tends to allow any person who is appropriately qualified by nature of training or experience - which can and is often interpreted to include scientists and engineers who are by training and experience intimately acquainted with and qualified to make sound conclusions from their review of Clincal Data. In Australia the interpretation is more strict - the TGA expects Clinical Evaluations to be signed by an appropriately clinically qualified person - meaning in general a physician but in some cases another clinical professional such as a nurse.

Click here to read the broader discussion on LinkedIn (log in required)

every device must have within the Technical File Clinical Evidence to support its compliance with the Annex I Essential Requirements.

Clinical Evidence = Clinical Data + Clinical Evaluation

Clinical Data may, depending on the device nature and risk, be comprised of any mixture of literature, preclinical and engineering data and human clinical trial data,

Clinical Evaluation is the expert report which reviews the Clinical Data and reaches conclusions about compliance with the Essential Requirements based on that review and in particular the clinical performance of the device.

The Clinical Evaluation Report is a key part of the Technical File and needs to be updated from time to time as the device design evolves or more information comes to hand from postmarket experience - e.g. postmarket trials or from customer feedback, adverse events or other information which impact on the conclusions.

One last thing. Interpretations vary around the world (in other GHTF-model jurisdictions) as to who is qualified to sign off a Clinical Evaluation. The European interpretation tends to allow any person who is appropriately qualified by nature of training or experience - which can and is often interpreted to include scientists and engineers who are by trainaing and experience intimately acquainted with and qualified to make sound conclusions from their review of Clincal Data. In Australia the interpretation is more strict - the TGA expects CLinical Evaluations to be signed by an appropriately CLINICALLY qualified person - meaning in general a physician but in some cases another clinical professional such as a nurse.