Medical  Device   &  QA  Consultancy

To meet the ESSENTIAL REQUIREMENTS # 3 and # 14 OF ANNEX I.....

 ....in accordance with EITHER clause 1 OR clause 2 of ANNEX  X

In order to comply with Clinical Data requirements, a Clinical Report must be generated, to prove the safety, performance and efficacy of the product in question. In order to accomplish this, the following must be documented for ALL Class of medical device;

1 - Make a list of, and acquire copies of, any relevant published Scientific Literature, concerning the Technology being used, the Clinical Environment in which the product is being used and the Performance Claims being made.

2 - Review the Scientific Literature and make a reference to any paragraphs, pages or sections that refer to the Technology that you are utilising and also the Performance Claims that you are making.

3 - The objective is to be able to demonstrate the safety and efficacy of YOUR device, comparing the Performance, Clinical, Technology and Safety features of your device, with references within the published literature.
 

4 - This could be supplemented by any Clinical Evaluation data gained from Trials or Evaluations of your Product, to demonstrate that Intended Performance Claims were indeed achieved..

5 - So in summary;

i - Define some objectives for what you wish the outcome of your Clinical Data Report to be, (eg: that Performance claims of ER # 3 have been met; that the device is as safe as any other on the market; that you are using latest state of the art technology; that clinical outcomes will benefit patients; etc; etc).
ii - Make a reference to the published data and also your Clinical Evaluation data.
iii - Discuss the data referred to in [2] above, at a level and detail relevant to the product in question.
iv - Arrive at a conclusion, that the objectives set out in [i] above have been met.
v - Have an 'appropriately qualified person' (probably clinically qualified) sign off the report.
 

6 - The prime objective of all the above is to demonstrate that clause 1 of Annex X is applicable to the product in question, rather than clause 2.

7 - If Clause 2 of Annex X were to be applicable, then a  clinical Trial would have to be embarked upon, in order to demonstrate the safety and efficacy of a New Material or New Technology, which has not been placed on the market previously. 

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Copyright © 2001  Medical Device & QA Consultancy. All  rights reserved.
Revised: October 07, 2002 .