Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD
3 May 2023
In February 2023, the European Association of Medical devices Notified Bodies, or Team NB, published the position paper „Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746“ stating that “manufacturers of all Classes of IVD medical devices are expected to demonstrate conformity of the IVD medical device to the General Safety and Performance Requirements of the IVD Medical Devices regulation through the preparation and holding of technical documentation that shows how each IVD medical device was developed, designed, and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity. This technical documentation is intended to reflect the current status of the IVD medical device through application of the manufacturer’s QMS.”
This technical documentation submission guidance corresponds to the requirements of In Vitro Diagnostic Medical Devices Regulation [IVDR] (EU) 2017/746, specifically in Annexes II and III, and Article 29.
The position paper underlines the purpose of the technical documentation which is:
- to reflect the status of the IVD medical device at a particular moment in time, e.g. in the pre-market or post-market phase,
- to meet the applicable regulatory requirements and more specifically the general safety and performance requirements (GSPR).
The technical documentation submitted to a NB needs to be provided in a language acceptable to the reviewing organisation.
