How to create a Notified Body compliant Technical Documentation?

Recommendation

6/7 February 2024

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One of the most important documents in the context of medical device regulation is the technical documentation. The requirements for this technical documentation are described on just over 3 pages in Annex II of the Medical Devices Regulation 2017/745. Further, Annex III describes the requirements for a technical Documentation for post-market surveillance (1 page).

For the technical documentation as described in the above mentioned Annex II and III, there is a helpful position paper of the Team Notified Body as a best practice guide. This provides a coordinated approach to the expectations of Notified Bodies with regard to technical documentation. The document was reissued in April as version 2.

The document interestingly starts with the most common deficiencies Notified Bodies found in technical documentation. These are:

• An incomplete submission: insufficient or missing information for the conformity procedures, such as incomplete or inconsistent description of the medical device. 
• Lack of a uniform structure: the information is available but difficult to find.

To remedy this situation, the position paper has been prepared and provides practical tips:

• Communicate with the Notified Body before a submission 
• Contents of the technical documentation for a submission 
• Facilitate the use of evidence still coming from the old directives

Following the document, which comprises a total of 47 pages, provides very specific guidelines for the implementation of a technical documentation with regard to

• Description of the product and manufacturing information 
• Information coming from the manufacturer 
• Design and manufacturing information 
• Basic safety and performance requirements 
• Benefits of risk analysis and risk management 
• Product verification and validation 
• Medical devices containing medicinal products and biological materials 
• Sterilisation and reprocessed surgical instruments 
• Clinical evaluation 
• Market surveillance 

Conclusion: The Best Practice Guide provides coordinated assistance for the preparation of technical documentation for medical devices. 

You can find the position paper on the Team NB website.