Team-NB revises the best practice guidance for the submission of technical documentation for medical devices
2 May 2023
On 19th April 2023, the European Association of Medical devices Notified Bodies, or Team-NB, published Version 2 of the position paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745”.
The best practice guidance document has been harmonised with the requirements of Medical Devices Regulation [MDR] (EU) 2017/745 and is intended “to develop a unified approach on the expectations of technical documentation submissions from manufacturers”. At the same time, Team-NB emphasises that additional information beyond the scope of the requirements described in the guidance might still be requested to be submitted during an assessment of the technical documentation. Furthermore, each notified body reserves the right to request additional information.