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.

Fresh approach for ISO 14155 – International standard for the Clinical Investigation of Medical Devices

A revised version of  the clinical evaluation standard ISO 14155, the international standard for the clinical investigation of medical devices was released earlier this year, and sees a number of updates and changes to the standard. The new standard combines the previous two standards of ISO14155 (Part 1 and 2) into one and has been reformed to level the playing field for clinical investigations conducted around the world – both economically and ethically.

ISO 14155 is not as well recognised as other ISO standards, with Japan and the U.S FDA failing to accept the old standard.  It has been argued that the standard lacks essential details and content, which are challenging to include in a document that needs to be flexible enough to pertain to clinical evaluations conducted all over the world under different conditions. However, the rewrite has been harmonised with ICH GCPs where possible while still remaining device-specific. The new approach deals with clinical research from a project management perspective, with the inclusion of sufficient narrative to teach a sponsor how to conduct a clinical investigation.