Medical Devices – Latest Updates

Best practice guidance for the submission of technical documentation under Annex II and III of the MDR

12 October 2022

On October 5, 2022, the European Association for Medical Devices of Notified Bodies (Team NB) published a new position paper in connection with the implementation of the regulations on medical devices and on in-vitro diagnostics.

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.

This technical documentation submission guidance is aligned to the requirements of Medical Devices Regulation MDR (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.

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