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A Summary of the European Commission’s EVALUATION OF CLINICAL DATA: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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RISK ANALYSIS AND CLINICAL ANALYSIS

Identifying foreseeable hazards associated with use of the device the manufacturer can decide on how best to deal with the risk while weighing it on the intended benefit. In circumstances where the clinical data is not sufficient to address the identified clinical hazards, a clinical investigation will be required.

There should be both technical and clinical parts to your risk analysis paying special attention to distinguishing between: The specific use of device (Intended Use), The technical solutions adopted (risks versus benefits of different technologies) and the comparison amongst your device and the historical methods/equipment (highlighting aspects specific to the design and use of your device).

LITERATURE ROUTE

Having the option of using Literature as a means for clinical data requires that the manufacturer assess the level of relevance to the device.  It can be difficult sometimes to separate the benefit of going via the Literature route (obviously a lot cheaper and expedited) and whether or not the data adequately addresses the safety and efficacy of the device.  An organization however can mitigate the effects of any bias (sometimes subconsciously generated) by carefully selecting the person who will review the data.

Reviewing Literature

The reviewer should be selected carefully to ensure that:

a)     He/she is impartial (demonstrates objectivity)

b)     Qualified in the relevant field (i.e. Orthopaedic Surgeon, etc)

c)      Up to date with the latest in the development of the particular field

What you need to do if you are thinking on submitting clinical data via the Literature Route?

Protocol

Just as in the case of a clinical investigation Literature reviews should begin with a protocol. The protocol should have a clearly defined objected while specifying how the systematic review for literature will proceed.

 The protocol should have the following:

1)     Identification of Literature

2)     Selection of Literature

3)     Collation of Literature

4)     And review of relevant studies

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