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25 September 2011

Comments

Bjorn Sowden

An interesting article, but I have one problem with ISO 14155:2011, as it apparently combines parts 1 & 2 of the original 14155 standard, but fails to mention Clinical EVALUATION even once (indeed the only reference - in section 7.3 - was an error which was corrected in a subsequent Technical Corrigendum).
Whilst the need for, and process of, a Clincial Evaluation was described in section 4 and Annex A of ISO 14155-1:2003, this is no longer metioned in the 2011 version. If one was being pedantic, one might say that this leaves MEDDEV 2.7.1 r3 stranded, as it references a defunct standard, and a requirement that no longer exists in the current standard.
Lacking any preamble, ISO 14155 dives straight into the process of Clinical Investigation, starting with Ethical Considerations, apparently not requiring any justification to do, or not to do, such an investigation . . .
Or have I missed something ?
Some insight on this matter would be welcome.

Nancy J Stark

Hello Bjorn,
This is a good question, I feel the discussion of clinical evaluations is much too well hidden--many people have trouble finding it.

Look at clause 5.3 in ISO 14155 (2011). It reads, "The justification for the design of the clinical investigation shall be based on the evaluation of pre-clinical data and the results of a clinical evaluation...."

Hope this helps, Nancy

Marge Walls-Walker

Nancy,
Nice summary of principle of 10993-1; however we need to remain mindful that many APAC Regulatory bodies and a few in South America AND on ocassion our own FDA do not fully subscribe to the literature/risk assessment/risk management approach to biological safety even though it has been the underlying principle since the first edition. As long as the Table exists and its "easy", the efforts to reduce/eliminate animal testing based on fidings in the literature and toxicological databases is going to remain an uphill struggle.
Best

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