TEAM-NB publishes position paper on Technical File reviews

TEAM-NB, the industry association for European notified bodies designated under MedTech regulations, has published a position paper titled ‘Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 – Information to be supplied by the manufacturer – a collaborative notified body approach’.

The 44-page 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”. The paper also confirms that the “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”.

The position paper apparently takes into account the assessment flexibility encouraged in MDCG 2022-14, in particular with reference to previous certifications under the AIMDD/MDD, so as to “to avoid unnecessary duplication of work, the MDCG encourages notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the Directives”.