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Technical file and clinical evaluation

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Guest user Created:   Jun 14, 2021 Last commented:   Jun 16, 2021

Technical file and clinical evaluation

With the combined package for ISO 13485 and MDR, do we need any external assistance with the technical file and clinical evaluation? i.e. a healthcare professional

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 16, 2021

Yes, absolutely. Considering the MDR part of the toolkit we have prepared general documents – A technical file that guides you on which information it has to have, then templates for the Post-market surveillance system and clinical evaluation report. However, according to Annex II in the MDR, there is a lot of documentation that is necessary, and which depends on the type of medical device. These are, for example, various stability studies, performance testing, sterilization validation documentation, packaging validation, and the like. Given the diversity of medical products, it was not possible to standardize all of this and make templates. 

As for healthcare professionals regarding the clinical evaluation, it is recommended that this be done by an independent person who is well acquainted with the product itself and, above all, with its medical purpose. Clinical evaluation should be understood as a key document that has all the necessary information to understand the medical device and to prove its purpose. It is a comprehensive document, very detailed and extensive. Therefore, it is extremely important that it is written by a competent person. If you have one in your company, then it is the best option, but if you do not have one, then it is good to look for a competent person to perform this task.

For more information, see:

For more information regarding the technical documentation structure please see the following link:

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