How to create a Notified-Body-compliant Technical Documentation

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

To facilitate technical documentation as described in Annex II and III, the Team Notified Body has created a helpful position paper as a best practice guide. Thus, a harmonized approach regarding the expectations of notified bodies for technical documentation is available. The document was reissued in April as version 2.

Interestingly, the document begins with the most common deficiencies that notified bodies found in technical documentation. These are:

  • An incomplete application: 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 compiled and provides practical tips:

  • Communicate with the notified body before a submitting an application
  • Contents of the technical documentation for a an application
  • Facilitations based on evidence still coming from the old directives

Furthermore, 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 device and specifications
  • Information coming from the manufacturer
  • Design and manufacturing information
  • General safety and performance requirements (GSPRs)
  • Benefits of risk analysis and risk management
  • Product verification and validation
  • Medical devices that include drugs and biological materials
  • Sterilisation and reusable surgical instruments
  • Clinical evaluation
  • Post 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.

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