This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents (exceeding twenty in number) 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 AnnexesII and III of Regulation (EU) 2017/745.