There are numerous challenges related to Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices (MDR and IVDR) respectively.
Among those, the availability of notified bodies was and is one of the core issues. In this context, it is within the interest of notified bodies and manufacturers that conformity assessment procedures move forward as smooth as possible.
To facilitate this process and to help manufacturers preparing appropriate submissions, Team-NB recently published and updated position papers where recommendations are provided what aspects should be regarded in technical documentation submissions.
Team-NB is the European association for medical device notified bodies. Their guidance represents the perspective of member organizations and is an important indicator for manufacturers regarding MDR and IVDR related expectations.
Should you wish to learn more and/ or have mdi Europa sending you the aforementioned position papers, please let us know.